Testosterone

also known as AndroGel · Testim · Natesto · Testosterone MD-Lotion · FE 999303 · Testogel · Androderm · Fortesta · +29 more

Small molecule targets IL6 via inhibition

Developed for: hypogonadism · hypogonadism, male · hypoactive sexual desire disorder · type 2 diabetes mellitus · muscular atrophy · obesity disorder · prostate cancer · erectile dysfunction
+75 more
· infertility disorder · sexual disorder · hypogonadotropic hypogonadism · breast cancer · female infertility · metabolic syndrome X · multiple sclerosis · osteoporosis · spinal cord injury · Alzheimer disease · body integrity dysphoria · cancer · constitutional delay of growth and puberty · depressive disorder · eye adnexa disorder · heart failure · HIV wasting syndrome · long QT syndrome · ovarian disorder · peripheral vascular disease · 46 XY differences of sex development · amyotrophic lateral sclerosis · anxiety · arthropathy · bone disorder · brain injury · bulbospinal muscular atrophy · cancer of unknown primary site · castration-resistant prostate carcinoma · chronic pain syndrome · chronic renal failure syndrome · cognitive disorder · cognitive impairment with or without cerebellar ataxia · congenital hypogonadotropic hypogonadism · coronary artery disorder · COVID-19 · ductal breast carcinoma in situ · endocrine system disorder · female orgasmic disorder · HIV infectious disease · hypopituitarism · Kallmann syndrome · kidney failure · Klinefelter syndrome · Leydig cell hypoplasia · male breast carcinoma · male infertility · metastatic prostate carcinoma · mood disorder · musculoskeletal system disorder · myopathy · opiate dependence · osteoarthritis, hip · ovarian dysfunction · panhypopituitarism · periodontitis · postmenopausal atrophic vaginitis · priapism · prostate carcinoma · prostate disorder · rotator cuff syndrome · urinary tract infection · vaginal disorder · vulvodynia · anorexia nervosa · atherosclerosis · benign prostatic hyperplasia · dry eye syndrome · eyelid disorder · female stress incontinence · major depressive disorder · Peyronie disease · postmenopausal osteoporosis · premature menopause · primary ovarian failure
Investigated by: Solvay Pharmaceuticals · Acerus Pharmaceuticals Corporation · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · National Institute on Aging (NIA) · University of Washington · Eli Lilly and Company
+184 more
· Warner Chilcott · VA Office of Research and Development · Ferring Pharmaceuticals · GlaxoSmithKline · Gulhane School of Medicine · The University of Texas Medical Branch, Galveston · University of Colorado, Denver · AbbVie · BioSante Pharmaceuticals · Massachusetts General Hospital · Mayo Clinic · National Cancer Institute (NCI) · Washington University School of Medicine · Abbott · Barnsley Hospital · Emotional Brain NY Inc. · Endo USA Inc., a Keenova Therapeutics Company · Memorial Sloan Kettering Cancer Center · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institutes of Health (NIH) · University of California, Los Angeles · Acrux DDS Pty Ltd · Alliance for Clinical Trials in Oncology · Boston University · Charles Drew University of Medicine and Science · Harvard University · Indiana University · Johns Hopkins University · Kimberly Myer · La Fe Health Research Institute · Laboratorios Andromaco S.A. · Merck Sharp & Dohme LLC · National Center for Research Resources (NCRR) · National Heart, Lung, and Blood Institute (NHLBI) · Parc de Salut Mar · Population Council · Purdue University · Seattle Institute for Biomedical and Clinical Research · Unimed Pharmaceuticals · University Hospital Muenster · University Medical Center Groningen · University at Buffalo · University of Miami · University of Southern California · University of Texas at Austin · University of Utah · Watson Pharmaceuticals · Acerus Biopharma Inc. · Advanced Therapies Centre, The London Clinic · Allergan · American Diabetes Association · American Federation for Aging Research · American Heart Association · American Hip Institute · American Psychological Association (APA) · American Urological Association · Antares Pharma Inc. · Aristotle University Of Thessaloniki · Assistance Publique - Hôpitaux de Paris · AstraZeneca · Azidus Brasil Scientific Research and Development Ltda · Bayer · Baylor College of Medicine · Beersheva Mental Health Center · Besins Healthcare · Biolab Sanus Farmaceutica · Boston Medical Center · Bradley Nindl · Brush Clinical Research Ltd. · Cancer League of Colorado · Cedars-Sinai Medical Center · Chelsea and Westminster NHS Foundation Trust · Children's Hospital Colorado · City of Hope Medical Center · all 190 on the full record

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed hypogonadism, male 3 milestones
Filed	US (FDA)	TLANDO	hypogonadism, male	2022-02-03	“the U.S. Food and Drug Administration ("FDA") has accepted its New Drug Application ("NDA") resubmission for TLANDO ® (testosterone undecanoate).” lipocine.com ↗ “The FDA accepted a New Drug Application ("NDA") resubmission for TLANDO® (testosterone undecanoate)” lipocine.com ↗
Filed	US (FDA)	TLANDO	hypogonadism, male	2019-05-14	“FDA has accepted its New Drug Application ("NDA") for TLANDO as testosterone replacement therapy ("TRT")” lipocine.com ↗ “Filed a New Drug Application ("NDA") for TLANDO™ as testosterone replacement therapy ("TRT")” lipocine.com ↗
Filed	US (FDA)	Axiron	hypogonadism, male	2011-11-02	“The new drug application for Axiron is currently under regulatory review by the FDA for the treatment of testosterone deficiency (hypogonadism) in men.” lilly.com ↗ “Previously, on November 2, 2011, Perrigo announced that it filed with the FDA a New Drug Application for testosterone gel 1.0%” perrigo.com ↗ “it has filed with the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for testosterone gel 1.0%” perrigo.com ↗ “The new drug application for AXIRON is currently under regulatory review by the U.S. Food and Drug Administration” lilly.com ↗
Withdrawn Indication not stated 5 milestones
Withdrawn	EU (EMA)	Intrinsa	—	2012-05-25	europa.eu ↗
Label expansion	US (FDA)	ANDRODERM	—	2011-10-20	fda.gov ↗
Approved	EU (EMA)	Intrinsa	—	2006-07-28	europa.eu ↗
Label expansion	US (FDA)	ANDROGEL	—	2005-08-11	fda.gov ↗
Approved	US (FDA)	TESTOPEL	—	1972-07-13	fda.gov ↗

Trials 216 · started per year

today

US approved 1972

EU approved 2006

19711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 07 trials · 1 met primary
Phase 0	NCT04717362	Mar → Dec 2024	hypogonadism, male, male infertility	Baylor College of Medicine	Withdrawn	No outcome recorded Stop: Enrollment
Phase 0	NCT03734653	Jan 2019 → Aug 2024	castration-resistant prostate carcinoma	University of Colorado, Denver	Completed	No outcome recorded
Phase 0	NCT03864913	Jan 2018 → Jun 2019	—	Oregon Health and Science University	Completed	No outcome recorded
Phase 0	NCT05781685	Oct 2017 → Jul 2018	—	University of New Mexico	Completed	No outcome recorded
Phase 0	NCT02679274	Feb → Sep 2016	—	The University of Texas Medical Branch, Galveston	Terminated	No outcome recorded Stop: Business
Phase 0	NCT01940718	Mar 2014 → Jan 2016	hypogonadism, male, priapism, sickle cell disease	Johns Hopkins University	Withdrawn	No outcome recorded Stop: Business
Phase 0	NCT01697345	Feb → Apr 2013	breast cancer, vaginal disorder	Creighton University	Completed	Met primary
Phase 134 trials · 3 met primary
Phase 1	NCT04207684	Feb 2020	—	Parc de Salut Mar	Completed	No outcome recorded
Phase 1	NCT04166786	May → Sep 2019	—	Parc de Salut Mar	Completed	No outcome recorded
Phase 1	NCT03345797	Mar 2018 → Apr 2020	hypogonadism	Acerus Biopharma Inc.	Terminated	No outcome recorded
Phase 1	NCT03314298	Aug 2017 → Apr 2018	breast disorder	Havah Therapeutics Pty Ltd	Completed	No outcome recorded
Phase 1	NCT02667561	Jul → Dec 2017	—	Biolab Sanus Farmaceutica	Withdrawn	No outcome recorded
Phase 1	NCT02994602	Jan → Jun 2017	—	Kimberly Myer	Completed	No outcome recorded
Phase 1	NCT02966652	Nov 2016 → Oct 2018	hypogonadism, male	Neurocrine UK Limited	Completed	No outcome recorded
Phase 1	NCT02990533	Sep 2016 → Nov 2020	—	The University of Texas Medical Branch, Galveston	Completed	No outcome recorded
Phase 1	NCT03967964	Nov 2015 → Jul 2016	—	Laboratorios Andromaco S.A.	Completed	No outcome recorded
Phase 1	NCT02432261	Apr 2015 → Mar 2016	—	Kimberly Myer	Completed	Met primary
Phase 1	NCT02268032	Jul 2014 → Aug 2016	female infertility	Laboratorios Andromaco S.A.	Completed	No outcome recorded
Phase 1	NCT02004132	Dec 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT02203656	Oct 2013 → Jul 2016	—	The University of Texas Medical Branch, Galveston	Completed	Met primary
Phase 1	NCT01862835	May 2013 → Sep 2016	—	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT01725451	Nov 2012 → Jan 2013	—	Eli Lilly and Company	Completed	Met primary
Phase 1	NCT01364623	Sep 2011 → Jan 2012	sexual disorder	Acerus Pharmaceuticals Corporation	Completed	No outcome recorded
Phase 1	NCT01167829	Jul → Oct 2010	—	University of Washington	Completed	No outcome recorded
Phase 1	NCT01160328	Jun 2010 → Jan 2013	obesity disorder	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT01130298	May 2010	—	AbbVie	Completed	No outcome recorded
Phase 1	NCT03118479	May → Sep 2010	Kallmann syndrome	Massachusetts General Hospital	Terminated	No outcome recorded
Phase 1	NCT01133548	May → Jul 2010	hypogonadism	AbbVie	Completed	No outcome recorded
Phase 1	NCT01104246	Apr → Sep 2010	hypogonadism	Watson Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT00996151	Dec 2009 → Feb 2010	hypogonadism	Acrux DDS Pty Ltd	Completed	No outcome recorded
Phase 1	NCT00998933	Oct 2009	hypogonadism	Solvay Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT00663793	Oct 2008 → May 2009	hypogonadism	University of Washington	Completed	No outcome recorded
Phase 1	NCT00647868	May 2008 → Mar 2009	hypogonadism, male	Acerus Pharmaceuticals Corporation	Completed	No outcome recorded
Phase 1	NCT00400335	Oct 2006 → ?	hypogonadism, male	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00957528	Jan 2006 → Dec 2008	hypogonadism	The University of Texas Medical Branch, Galveston	Completed	No outcome recorded
Phase 1	NCT00309855	Dec 2005 → Aug 2008	—	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT00969163	Oct 2004 → Apr 2005	—	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT00431197	Feb 2004 → Dec 2007	hypogonadism	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT00193700	Aug 2002 → ?	constitutional delay of growth and puberty, hypogonadism	Solvay Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT00006044	Feb 2000 → Feb 2005	prostate cancer	Memorial Sloan Kettering Cancer Center	Completed	No outcome recorded
Phase 1	NCT00705796	—	hypogonadism	Acerus Pharmaceuticals Corporation	Withdrawn	No outcome recorded Stop: Business

Phase 1/26 trials · 2 met primary · 1 missed
Phase 1/2	NCT07287800	Jul 2025 → Jun 2026 overdue	end stage renal failure, hypogonadism, male	University of California, Los Angeles	Active not recruiting	No outcome recorded
Phase 1/2	NCT02317640	Mar 2017 → Oct 2022	spinal cord injury	Kessler Foundation	Unknown	No outcome recorded
Phase 1/2	NCT01686828	Jun 2013 → May 2015	hypogonadism, obesity disorder, type 2 diabetes mellitus	University of Washington	Completed	Missed primary
Phase 1/2	NCT01873989	Apr 2012 → Jan 2015	chronic pain syndrome, hypogonadism, male, opiate dependence	Yale University	Completed	No outcome recorded
Phase 1/2	NCT00839319	Mar 2009 → Sep 2010	—	University of Washington	Completed	Met primary
Phase 1/2	NCT00405353	Apr 2002 → Mar 2007	multiple sclerosis	University of California, Los Angeles	Completed	Met primary
Phase 251 trials · 4 missed
Phase 2	NCT02733133	Jan → Oct 2027 expected	hypogonadotropic hypogonadism	Transdermal Delivery Solutions Corp	Not yet recruiting	No outcome recorded
Phase 2	NCT07500766	Mar → Jun 2026 overdue	hypogonadism, male	University of Sao Paulo	Not yet recruiting	No outcome recorded
Phase 2	NCT06075953	Feb 2024 → Nov 2028 expected	ductal breast carcinoma in situ	QuantumLeap Healthcare Collaborative	Recruiting	No outcome recorded
Phase 2	NCT06084338	Dec 2023 → Nov 2027 expected	prostate cancer	VA Office of Research and Development	Recruiting	No outcome recorded
Phase 2	NCT05011383	Aug 2021 → Aug 2027 expected	metastatic prostate carcinoma	VA Office of Research and Development	Recruiting	No outcome recorded
Phase 2	NCT04492553	Apr 2021 → Nov 2022	hypogonadism, male	Lars Møller Pedersen	Completed	No outcome recorded
Phase 2	NCT04301765	Jan 2021 → Nov 2026 expected	cancer, hypogonadism, male	Seattle Institute for Biomedical and Clinical Research	Active not recruiting	No outcome recorded
Phase 2	NCT06794346	Oct 2020 → Oct 2024	hypogonadism, poisoning, sexual disorder	University of Sao Paulo General Hospital	Unknown	No outcome recorded
Phase 2	NCT03339635	Dec 2018 → Jun 2024	testicular cancer	University Medical Center Groningen	Completed	No outcome recorded
Phase 2	NCT03452111	Oct 2018 → Sep 2024	—	Premier Research	Completed	No outcome recorded
Phase 2	NCT03000127	Jul 2018 → Jun 2023	multiple sclerosis	University of California, Los Angeles	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT02101203	Jul 2013 → Aug 2014	hypoactive sexual desire disorder	Emotional Brain NY Inc.	Completed	No outcome recorded
Phase 2	NCT01469988	Nov 2012 → Apr 2014	heart failure	University of Alberta	Terminated	No outcome recorded
Phase 2	NCT01743235	Jul 2012 → Jun 2013	hypoactive sexual desire disorder	Emotional Brain NY Inc.	Completed	No outcome recorded
Phase 2	NCT01607658	May 2012 → May 2014	female orgasmic disorder	Acerus Pharmaceuticals Corporation	Completed	No outcome recorded
Phase 2	NCT01464879	Dec 2011 → May 2012	hypogonadism, male	Ferring Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01460654	Oct 2011 → May 2014	hypogonadism, osteoporosis	Massachusetts General Hospital	Terminated	No outcome recorded
Phase 2	NCT01432665	Sep 2011 → May 2013	hypoactive sexual desire disorder	Emotional Brain NY Inc.	Completed	No outcome recorded
Phase 2	NCT01419236	Aug 2011 → Dec 2013	hypogonadism, male, sexual disorder	Eli Lilly and Company	Completed	Missed primary
Phase 2	NCT01310647	Jun 2011 → Dec 2012	ovarian disorder	La Fe Health Research Institute	Completed	Missed primary
Phase 2	NCT01370369	May → Jul 2011	hypogonadism, male	Ferring Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01323140	Apr → Jul 2011	hypogonadism	Watson Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01252745	Aug → Nov 2010	hypogonadism	Acerus Pharmaceuticals Corporation	Completed	No outcome recorded
Phase 2	NCT01155518	Jun 2010 → Dec 2013	hypogonadotropic hypogonadism, type 2 diabetes mellitus	State University of New York at Buffalo	Terminated	No outcome recorded Stop: Business
Phase 2	NCT00975650	Aug 2009 → May 2010	hypogonadism, male	Acerus Pharmaceuticals Corporation	Completed	No outcome recorded
Phase 2	NCT00957034	Jul 2009 → Apr 2010	heart failure	Warner Chilcott	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00729859	Dec 2008 → May 2010	—	University of Washington	Completed	Missed primary
Phase 2	NCT00755183	Jul 2008 → Apr 2009	eye adnexa disorder	ORA, Inc.	Completed	No outcome recorded
Phase 2	NCT00577980	Dec 2007 → Jun 2008	prostate cancer	M.D. Anderson Cancer Center	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT00857961	Oct 2007 → Jan 2008	hypogonadism, male	Eli Lilly and Company	Completed	No outcome recorded
Phase 2	NCT00515112	Jul 2007 → Nov 2010	prostate cancer	University of Chicago	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00202163	Dec 2006 → Jul 2007	erectile dysfunction	Queen's University	Completed	No outcome recorded
Phase 2	NCT00398034	Oct 2006 → Sep 2007	hypogonadism	James J. Peters Veterans Affairs Medical Center	Withdrawn	No outcome recorded
Phase 2	NCT00372008	Oct 2006 → Apr 2007	hypogonadism	Acrux DDS Pty Ltd	Completed	No outcome recorded
Phase 2	NCT00398580	Oct 2006 → Oct 2007	hypogonadism, male	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00365794	Aug 2006 → Dec 2013	hypogonadism, obesity disorder	University of Southern California	Completed	No outcome recorded
Phase 2	NCT00382057	May 2006 → Mar 2011	metabolic syndrome X	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Withdrawn	No outcome recorded
Phase 2	NCT00161421	Mar 2005 → Jul 2006	hypogonadism, male	University of Washington	Completed	No outcome recorded
Phase 2	NCT00167141	Feb 2005 → Dec 2007	—	University Hospital Muenster	Terminated	No outcome recorded
Phase 2	NCT00112151	Jan 2005 → Nov 2010	—	University of Colorado, Denver	Completed	Missed primary
Phase 2	NCT00141492	Oct 2004 → Jun 2007	hypogonadism, type 2 diabetes mellitus	Solvay Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00280267	Aug 2004 → Dec 2006	hypogonadism	Washington University School of Medicine	Completed	No outcome recorded
Phase 2	NCT00080756	Mar 2004 → Sep 2024 overdue	BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, breast cancer	City of Hope Medical Center	Active not recruiting	No outcome recorded
Phase 2	NCT00104572	Mar 2004 → Dec 2013	depressive disorder, diabetes mellitus, hypogonadism, muscular atrophy +1	National Institute on Aging (NIA)	Completed	No outcome recorded
Phase 2	NCT00587431	Jul 2003 → Feb 2008	prostate cancer	Memorial Sloan Kettering Cancer Center	Completed	No outcome recorded
Phase 2	NCT00183040	Sep 2002 → Feb 2007	muscular atrophy	National Institute on Aging (NIA)	Completed	No outcome recorded
Phase 2	NCT00193661	Aug 2002 → Mar 2007	constitutional delay of growth and puberty, hypogonadism, male	Solvay Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00586898	Jul 2001 → Mar 2009	cancer, prostate disorder	Memorial Sloan Kettering Cancer Center	Completed	No outcome recorded
Phase 2	NCT00006158	Sep 1998 → Dec 2004	HIV wasting syndrome	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	No outcome recorded
Phase 2	NCT00004400	Apr 1997 → Sep 2001	HIV wasting syndrome	Charles Drew University of Medicine and Science	Completed	No outcome recorded
Phase 2	NCT00004771	Oct 1992 → ?	amyotrophic lateral sclerosis, bulbospinal muscular atrophy	National Center for Research Resources (NCRR)	Completed	No outcome recorded

Phase 2/37 trials · 1 met primary · 1 missed
Phase 2/3	NCT07260825	Dec 2025 → Jul 2026 overdue	psychologic dyspareunia, vulvar lichen sclerosus, vulvodynia	TriHealth Inc.	Not yet recruiting	No outcome recorded
Phase 2/3	NCT04345666	Aug 2021 → Aug 2022	rotator cuff syndrome	Orthopedic Institute, Sioux Falls, SD	Withdrawn	No outcome recorded Stop: Business
Phase 2/3	NCT02873559	Nov 2016 → Mar 2022	myopathy	University Hospital, Gentofte, Copenhagen	Completed	No outcome recorded
Phase 2/3	NCT02991209	Nov 2016 → Jun 2019	Leydig cell hypoplasia, metabolic syndrome X, testicular cancer	Mikkel Bandak	Completed	Missed primary
Phase 2/3	NCT02803073	Aug 2016 → Mar 2017	hypogonadism, male	Texas Tech University Health Sciences Center	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2/3	NCT01652040	Jul 2012 → Dec 2017	spinal cord injury	VA Office of Research and Development	Completed	No outcome recorded
Phase 2/3	NCT00266864	Aug 2003 → Aug 2012	hypogonadism, spinal cord injury	VA Office of Research and Development	Completed	Met primary
Phase 344 trials · 3 met primary · 5 missed
Phase 3	NCT06351501	Jun 2024 → Jun 2029 expected	body integrity dysphoria	Assistance Publique - Hôpitaux de Paris	Recruiting	No outcome recorded
Phase 3	NCT04831099	Jun 2021 → Jul 2022	46 XY differences of sex development	Erasmus Medical Center	Unknown	No outcome recorded
Phase 3	NCT04523480	Mar 2020 → Dec 2022	hypogonadism	University of Miami	Completed	No outcome recorded
Phase 3	NCT05722301	Nov 2019 → Nov 2020	osteoarthritis, hip	American Hip Institute	Withdrawn	No outcome recorded
Phase 3	NCT02938923	Mar 2019 → Aug 2023	bone disorder, muscular atrophy	Washington University School of Medicine	Completed	Missed primary
Phase 3	NCT03281187	Jul → Nov 2018	hypogonadism	FBM Industria Brasileira Ltda	Unknown	No outcome recorded
Phase 3	NCT03378713	Aug 2017 → Feb 2019	female infertility	La Fe Health Research Institute	Completed	No outcome recorded
Phase 3	NCT03238092	Aug 2017 → Jan 2018	infertility disorder	Hospital de Clinicas de Porto Alegre	Unknown	No outcome recorded
Phase 3	NCT03054168	Dec 2016 → Nov 2018	muscular atrophy	University of Nottingham	Unknown	No outcome recorded
Phase 3	NCT02418572	Apr 2015 → Dec 2023	infertility disorder, ovarian dysfunction	Fundacion Dexeus	Terminated	Missed primary
Phase 3	NCT02149264	Jul 2014 → May 2015	hypogonadism, male	Ferring Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT02081300	Feb 2014 → May 2015	hypogonadism, male	Lipocine Inc.	Completed	No outcome recorded
Phase 3	NCT02418065	Dec 2013 → Mar 2017	chronic renal failure syndrome	University Hospital, Clermont-Ferrand	Unknown	No outcome recorded
Phase 3	NCT01961336	Oct 2013 → Jun 2015	infertility disorder	Aristotle University Of Thessaloniki	Completed	Missed primary
Phase 3	NCT01573442	Sep 2013 → Feb 2018	arthropathy, breast cancer, sexual disorder	Alliance for Clinical Trials in Oncology	Completed	Mixed
Phase 3	NCT01816295	May 2013 → Oct 2014	hypogonadism	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01703741	Dec 2012 → Oct 2013	hypogonadism, male	Ferring Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01665599	Jul 2012 → Apr 2013	hypogonadism, male	Ferring Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01595581	Apr 2012 → May 2015	muscular atrophy, osteoarthritis	University of Southern California	Completed	No outcome recorded
Phase 3	NCT01446042	Sep 2011 → Dec 2012	hypogonadism, male	Acerus Pharmaceuticals Corporation	Completed	No outcome recorded
Phase 3	NCT01228071	Nov 2010 → May 2011	hypogonadism, male	Endo USA Inc., a Keenova Therapeutics Company	Completed	No outcome recorded
Phase 3	NCT01235754	Oct 2010 → Dec 2011	hypoactive sexual desire disorder	BioSante Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00539305	Jul 2009 → Jul 2011	Alzheimer disease, cognitive impairment with or without cerebellar ataxia	University of Washington	Completed	No outcome recorded
Phase 3	NCT00857454	Oct 2008 → Aug 2009	hypogonadism, male	Eli Lilly and Company	Completed	No outcome recorded
Phase 3	NCT00702650	Jun 2008 → Jul 2009	hypogonadism, male	Eli Lilly and Company	Completed	No outcome recorded
Phase 3	NCT00657501	Mar 2008 → Sep 2011	hypoactive sexual desire disorder	BioSante Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT02847806	Jan 2008 → Dec 2015	hypogonadism, male	University Hospital, Caen	Completed	No outcome recorded
Phase 3	NCT00612742	Jan 2008 → Oct 2012	hypoactive sexual desire disorder	BioSante Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00522431	Aug 2007 → Mar 2008	hypogonadism	Endo USA Inc., a Keenova Therapeutics Company	Completed	No outcome recorded
Phase 3	NCT00467259	Apr 2007 → Jan 2009	hypoactive sexual desire disorder	Warner Chilcott	Completed	Missed primary
Phase 3	NCT00433199	Feb → Oct 2007	hypogonadism	Abbott	Completed	No outcome recorded
Phase 3	NCT00413244	Jan 2007 → Jan 2014	coronary artery disorder	Icahn School of Medicine at Mount Sinai	Completed	Met primary
Phase 3	NCT00613002	Dec 2006 → Sep 2011	hypoactive sexual desire disorder	BioSante Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00384046	Nov 2006 → Jul 2007	hypoactive sexual desire disorder	Warner Chilcott	Completed	No outcome recorded
Phase 3	NCT00693108	Sep 2006 → ?	ovarian disorder	Hospital Clinic of Barcelona	Completed	No outcome recorded
Phase 3	NCT00244023	Oct 2005 → Jul 2007	erectile dysfunction, hypogonadism	SELARL du Dr Jacques BUVAT	Completed	No outcome recorded
Phase 3	NCT00140153	Apr 2005 → Apr 2006	hypoactive sexual desire disorder	Beersheva Mental Health Center	Completed	No outcome recorded
Phase 3	NCT00131495	Jul 2004 → Feb 2006	hypoactive sexual desire disorder	Warner Chilcott	Completed	Met primary
Phase 3	NCT00075855	Apr 2004 → May 2007	cancer of unknown primary site, sexual disorder	Alliance for Clinical Trials in Oncology	Completed	Missed primary
Phase 3	NCT00204269	Jan 2003 → Sep 2006	hypogonadism	University Hospital Muenster	Unknown	No outcome recorded
Phase 3	NCT00349791	Jun 2002 → Oct 2003	hypoactive sexual desire disorder	Warner Chilcott	Completed	No outcome recorded
Phase 3	NCT00338312	Jun 2002 → Dec 2004	hypoactive sexual desire disorder	Warner Chilcott	Completed	No outcome recorded
Phase 3	NCT00331214	Jun 2002 → Dec 2003	hypoactive sexual desire disorder	Warner Chilcott	Completed	No outcome recorded
Phase 3	NCT00331123	May 2002 → Dec 2003	hypoactive sexual desire disorder	Warner Chilcott	Completed	No outcome recorded

Phase 444 trials · 1 met primary · 4 missed
Phase 4	NCT04601233	Jun → Sep 2026	erectile dysfunction, hypogonadism, male, multiple sclerosis	Tulane University	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT06195163	Sep 2025 → Sep 2026 overdue	infertility disorder	Instituto Bernabeu	Not yet recruiting	No outcome recorded
Phase 4	NCT06733350	Jan 2025 → Jan 2029 expected	prostate carcinoma	Roswell Park Cancer Institute	Recruiting	No outcome recorded
Phase 4	NCT06253702	Jul 2024 → May 2025	cerebrovascular disorder	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT06455969	Jul 2024 → Aug 2026 overdue	hypogonadism, musculoskeletal system disorder	Bradley Nindl	Recruiting	No outcome recorded
Phase 4	NCT05381831	Jun 2022 → Apr 2025	hypogonadism, male	University of Florida	Completed	No outcome recorded
Phase 4	NCT04675788	Sep 2021 → Apr 2025	long QT syndrome	Indiana University	Completed	No outcome recorded
Phase 4	NCT04976595	Jul 2021 → Dec 2022	hypogonadism	Acerus Pharmaceuticals Corporation	Unknown	No outcome recorded
Phase 4	NCT04807894	Nov 2020 → Aug 2026	postmenopausal atrophic vaginitis, urinary tract infection	Jefferson Drapkin	Terminated	No outcome recorded
Phase 4	NCT04623385	Nov → Dec 2020	COVID-19	Kafrelsheikh University	Unknown	No outcome recorded
Phase 4	NCT04558567	Aug 2020 → Dec 2023	hypogonadism, male	Upsher-Smith Laboratories	Completed	No outcome recorded
Phase 4	NCT04320745	May 2020 → Jun 2021	hypogonadism, male	Allergan	Completed	No outcome recorded
Phase 4	NCT04274894	May 2020 → Dec 2021	hypogonadism	AbbVie	Completed	Missed primary
Phase 4	NCT03887936	Oct 2019 → Oct 2025	hypogonadism, type 2 diabetes mellitus	VA Office of Research and Development	Completed	No outcome recorded
Phase 4	NCT03203681	Oct 2017 → Jun 2020	hypogonadism, male	University of Miami	Completed	No outcome recorded
Phase 4	NCT02799277	Aug 2017 → May 2018	—	Robert Josephs	Completed	No outcome recorded
Phase 4	NCT03091348	Aug → Nov 2017	hypogonadism, male	Men's Health Boston	Completed	No outcome recorded
Phase 4	NCT03176537	May 2017 → Dec 2020	hypogonadism, male, periodontitis	Federal University of Paraná	Withdrawn	No outcome recorded
Phase 4	NCT03078569	Mar 2017 → Mar 2018	female infertility	Wolfson Medical Center	Unknown	No outcome recorded
Phase 4	NCT02715232	Feb 2017 → Dec 2020	body integrity dysphoria	Medical University of Vienna	Unknown	No outcome recorded
Phase 4	NCT02937740	Oct 2016 → Oct 2017	hypogonadism, male	Acerus Pharmaceuticals Corporation	Completed	No outcome recorded
Phase 4	NCT02513940	May 2016 → Oct 2017	long QT syndrome	Indiana University	Completed	Mixed
Phase 4	NCT02611154	Nov 2015 → Jan 2016	—	University of Utah	Completed	No outcome recorded
Phase 4	NCT01084369	Oct 2013 → Sep 2014	hypogonadism, male, type 2 diabetes mellitus	Tameside Hospital NHS Foundation Trust	Terminated	No outcome recorded
Phase 4	NCT01893281	Jul 2013 → Jan 2014	hypogonadism, male	Eli Lilly and Company	Completed	No outcome recorded
Phase 4	NCT02111434	Jul 2013 → Apr 2014	congenital hypogonadotropic hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT01208038	Mar 2011 → Feb 2012	hypoactive sexual desire disorder	Imperial College Healthcare NHS Trust	Completed	No outcome recorded
Phase 4	NCT01201863	Sep 2010 → Jul 2014	brain injury, endocrine system disorder	Craig Hospital	Completed	Missed primary
Phase 4	NCT01160341	Aug 2009 → Jan 2010	hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT02111473	May 2009 → May 2012	hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT01107067	Jun 2008 → Dec 2009	hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT01601327	Jan 2008 → Mar 2012	hypogonadotropic hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT00512707	Nov 2006 → May 2010	diabetes mellitus, erectile dysfunction, hypogonadism	Boston University	Completed	Missed primary
Phase 4	NCT00350701	Jul 2006 → Jun 2013	type 2 diabetes mellitus	University at Buffalo	Completed	No outcome recorded
Phase 4	NCT00349362	Jul 2006 → Oct 2008	hypogonadism, male, type 2 diabetes mellitus	Barnsley Hospital	Completed	No outcome recorded
Phase 4	NCT00304213	Mar 2006 → Apr 2009	hypogonadism	North Florida Foundation for Research and Education	Withdrawn	No outcome recorded
Phase 4	NCT00355537	Feb 2006 → Dec 2009	peripheral vascular disease, type 2 diabetes mellitus	Barnsley Hospital	Completed	No outcome recorded
Phase 4	NCT00504712	Feb 2006 → Dec 2009	hypogonadism, male, peripheral vascular disease, type 2 diabetes mellitus	Barnsley Hospital	Completed	No outcome recorded
Phase 4	NCT00240981	Jan 2005 → Dec 2009	hypogonadism, muscular atrophy	Boston Medical Center	Terminated	Met primary
Phase 4	NCT01123278	Jan 2004 → Oct 2014	erectile dysfunction, hypogonadism, metabolic syndrome X, obesity disorder	University of Roma La Sapienza	Completed	No outcome recorded
Phase 4	NCT00144391	Jul 2003 → Dec 2010	panhypopituitarism	Charles Drew University of Medicine and Science	Completed	Missed primary
Phase 4	NCT00182871	Nov 2001 → Jul 2007	osteoporosis	National Institute on Aging (NIA)	Completed	No outcome recorded
Phase 4	NCT00018356	Jan 1999 → Jul 2006	muscular atrophy	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 4	NCT00009555	? → Mar 2006	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase not applicable23 trials · 2 met primary · 1 missed
—	NCT07212712	Apr → Dec 2026 expected	vascular disorder	University of British Columbia	Not yet recruiting	No outcome recorded
—	NCT07568574	Mar 2026 → May 2028 expected	—	Enhanced Emirates Limited	Enrolling by invitation	No outcome recorded
—	NCT05156606	Nov 2022 → Jul 2024	male breast carcinoma	University Medical Center Groningen	Terminated	No outcome recorded Stop: Enrollment
—	NCT04819204	Jun 2021 → Dec 2023	—	Western University, Canada	Unknown	No outcome recorded
—	NCT07168265	Jan → Aug 2020	eye adnexa disorder, hypogonadism, male	Neon Hospital	Completed	No outcome recorded
—	NCT04602143	Feb 2018 → Jun 2020	infertility disorder	Hanoi Medical University	Completed	No outcome recorded
—	NCT02361190	Feb 2015 → Apr 2016	anxiety	University of Texas at Austin	Completed	No outcome recorded
—	NCT02134470	Apr 2014 → Dec 2015	circadian rhythm sleep disorder	Paracelsus Medical University	Unknown	No outcome recorded
—	NCT01585831	Mar 2012 → Oct 2017	Klinefelter syndrome	University of Colorado, Denver	Completed	No outcome recorded
—	NCT01408498	Jan → Apr 2012	—	University of Texas at Austin	Completed	No outcome recorded
—	NCT01084759	Mar 2010 → Oct 2014	prostate cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Completed	No outcome recorded
—	NCT00805207	Sep 2007 → Mar 2013	obesity disorder, obstructive sleep apnea syndrome, polycystic ovary syndrome	Washington University School of Medicine	Completed	Missed primary
—	NCT00613288	Sep 2007 → Sep 2009	hypogonadism	University of Aarhus	Completed	No outcome recorded
—	NCT00645658	Aug 2007 → Aug 2010	kidney failure	Palo Alto Veterans Institute for Research	Completed	No outcome recorded
—	NCT00467987	Jun 2007 → Mar 2018	hypogonadotropic hypogonadism	University at Buffalo	Terminated	No outcome recorded
—	NCT00392912	Apr 2007 → Nov 2009	Alzheimer disease, hypogonadism	Michael E. DeBakey VA Medical Center	Completed	No outcome recorded
—	NCT00983554	Jun 2005 → May 2009	obesity disorder	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Unknown	No outcome recorded
—	NCT00680797	Jan 2005 → Dec 2013	—	VA Office of Research and Development	Completed	No outcome recorded
—	NCT00114114	Sep 2004 → Nov 2017	—	Massachusetts General Hospital	Completed	No outcome recorded
—	NCT00202462	Nov 2002 → Dec 2005	depressive disorder, hypogonadism	Seattle Institute for Biomedical and Clinical Research	Completed	Met primary
—	NCT00027430	Sep 2001 → Dec 2004	hypopituitarism	Massachusetts General Hospital	Completed	Met primary
—	NCT00006129	Jun 2000 → ?	—	National Center for Research Resources (NCRR)	Unknown	No outcome recorded
—	NCT00000175	? → Jun 2005	cognitive disorder, mood disorder	National Institute on Aging (NIA)	Terminated	No outcome recorded

Comparator or background therapy90 trials
Phase 0	NCT06393634 Comparator	Nov 2024	—	Sports Medicine Research and Testing Laboratory	Completed	No outcome recorded
Phase 0	NCT06130449 Comparator	Apr 2024 → Dec 2026 expected	spinal cord injury	VA Office of Research and Development	Recruiting	No outcome recorded
Phase 0	NCT02256865 Comparator	Oct 2014 → Nov 2017	—	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Completed	No outcome recorded
Phase 0	NCT00848497 Comparator	Nov 2007 → Mar 2013	erectile dysfunction, hypogonadism	Mohit Khera	Terminated	No outcome recorded Stop: Business
Phase 1	NCT02712944 Comparator	Jul 2016 → Mar 2018	hypogonadism	Texas Tech University Health Sciences Center	Terminated	No outcome recorded
Phase 1	NCT01578473 Comparator	May → Jul 2013	Peyronie disease	Men's Health Boston	Completed	No outcome recorded
Phase 1	NCT01096329 Comparator	Feb → Apr 2010	hypoactive sexual desire disorder	VIVUS LLC	Terminated	No outcome recorded
Phase 1	NCT00891228 Background	May 2009 → May 2010	—	Premier Research	Completed	No outcome recorded
Phase 1	NCT00857168 Comparator	Jan → Feb 2009	hypogonadism	Acrux DDS Pty Ltd	Completed	No outcome recorded
Phase 1	NCT00816712 Comparator	Jan → Dec 2008	—	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT00812396 Comparator	Nov 2007 → Feb 2008	—	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT00438321 Comparator	Sep 2006 → Feb 2010	metabolic syndrome X	Massachusetts General Hospital	Terminated	No outcome recorded
Phase 1	NCT00229593 Comparator	Sep 2005 → Jan 2007	—	University of Washington	Completed	No outcome recorded
Phase 1/2	NCT02229617 Comparator	Jul 2015 → May 2016	body integrity dysphoria	University of British Columbia	Completed	No outcome recorded
Phase 1/2	NCT01662466 Comparator	Jul 2012 → Jun 2022	female infertility, primary ovarian failure	Center for Human Reproduction	Unknown	No outcome recorded
Phase 1/2	NCT00161447 Comparator	May 2004 → Apr 2006	—	University of Washington	Completed	No outcome recorded
Phase 2	NCT01894308 Comparator	Jun → Oct 2027 expected	hypogonadotropic hypogonadism	Transdermal Delivery Solutions Corp	Not yet recruiting	No outcome recorded
Phase 2	NCT07254429 Comparator	Oct 2025 → Dec 2027 expected	postmenopausal osteoporosis	Martin Blomberg Jensen	Recruiting	No outcome recorded
Phase 2	NCT05825092 Comparator	Jul 2023 → Sep 2025 overdue	—	University Hospital, Clermont-Ferrand	Recruiting	No outcome recorded
Phase 2	NCT06154200 Comparator	Apr 2023 → Apr 2024	dry eye syndrome, eyelid disorder	Southern California College of Optometry at Marshall B. Ketchum University	Completed	No outcome recorded
Phase 2	NCT03678233 Comparator	Jun 2019 → Jun 2025	hypogonadism, muscular atrophy	University Hospital, Clermont-Ferrand	Unknown	No outcome recorded
Phase 2	NCT02147964 Background	Jun 2019 → Dec 2021	hypogonadotropic hypogonadism	University of Washington	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT03345576 Comparator	Jul 2018 → Jun 2023	spinal cord injury	VA Office of Research and Development	Completed	No outcome recorded
Phase 2	NCT03210558 Comparator	May 2017 → Jun 2018	—	Karolinska University Hospital	Completed	No outcome recorded
Phase 2	NCT02445716 Comparator	Oct 2015 → Oct 2017	—	University Potiguar	Unknown	No outcome recorded
Phase 2	NCT01616732 Comparator	Apr 2013 → Nov 2015	—	Austin Health	Completed	No outcome recorded
Phase 2	NCT01386567 Comparator	Jul 2011 → Jan 2013	hypogonadism, male	Repros Therapeutics Inc.	Completed	No outcome recorded
Phase 2	NCT01386606 Comparator	Jun → Oct 2011	hypogonadotropic hypogonadism	Repros Therapeutics Inc.	Completed	Missed primary
Phase 2	NCT01270841 Comparator	Jan → Dec 2011	hypogonadotropic hypogonadism	Repros Therapeutics Inc.	Completed	No outcome recorded
Phase 2	NCT01121211 Comparator	Apr 2010 → Feb 2016	anorexia nervosa, anxiety, depressive disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 2	NCT02215434 Comparator	Sep 2009 → Apr 2013	—	University Potiguar	Completed	No outcome recorded
Phase 2	NCT00706719 Comparator	Jun 2008 → Jul 2009	hypogonadotropic hypogonadism	Repros Therapeutics Inc.	Completed	Mixed
Phase 2	NCT00497458 Comparator	Jul 2007 → Apr 2009	arthropathy, breast cancer, osteoporosis	Havah Therapeutics Pty Ltd	Unknown	No outcome recorded
Phase 2	NCT00351819 Comparator	Apr 2006 → Nov 2012	hypogonadism	Boston University	Completed	No outcome recorded
Phase 2	NCT00254553 Comparator	Jul 2005 → Jan 2007	hypogonadism	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00080483 Comparator	Mar 2004 → Sep 2010	hypogonadism, hypopituitarism, pituitary deficiency	University of Pennsylvania	Completed	Missed primary
Phase 2	NCT02317263 Comparator	? → Jan 2099	multiple sclerosis	University of California, Los Angeles	Withdrawn	No outcome recorded Stop: Business
Phase 2/3	NCT01797718 Comparator	Oct 2013 → Mar 2017	constitutional delay of growth and puberty	Helsinki University Central Hospital	Completed	No outcome recorded
Phase 2/3	NCT01327495 Comparator	Oct 2011 → Jun 2014	—	University of Washington	Completed	No outcome recorded
Phase 2/3	NCT00089843 Comparator	Jun 2003 → Apr 2008	anorexia nervosa	Massachusetts General Hospital	Completed	No outcome recorded
Phase 3	NCT06343870 Comparator	Dec 2025 → Aug 2026 overdue	hypogonadism, premature menopause	University of Sao Paulo General Hospital	Recruiting	No outcome recorded
Phase 3	NCT05894954 Background	Jul 2023 → Oct 2025	cognitive impairment with or without cerebellar ataxia, dementia	Alzheimer's Prevention and Reversal Project, Inc.	Completed	No outcome recorded
Phase 3	NCT04833426 Comparator	Dec 2022 → Dec 2027 expected	hypogonadism, male, prostate cancer	Canisius-Wilhelmina Hospital	Recruiting	No outcome recorded
Phase 3	NCT03198728 Comparator	Jul 2017 → May 2020	hypogonadism, male	Marius Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT02722278 Comparator	Mar → Nov 2016	hypogonadism, male	Clarus Therapeutics, Inc.	Completed	No outcome recorded
Phase 3	NCT02419105 Comparator	Sep 2015 → May 2020	hypogonadism	University of Zurich	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT02367105 Comparator	Feb 2015 → Jul 2019	hypogonadism	VA Office of Research and Development	Completed	No outcome recorded
Phase 3	NCT01993225 Comparator	Jan → Aug 2014	hypogonadotropic hypogonadism	Repros Therapeutics Inc.	Completed	No outcome recorded
Phase 3	NCT01993212 Comparator	Jan → Sep 2014	hypogonadotropic hypogonadism	Repros Therapeutics Inc.	Completed	No outcome recorded
Phase 3	NCT01699178 Comparator	Aug 2012 → Apr 2014	hypogonadism, male	Clarus Therapeutics, Inc.	Completed	No outcome recorded
Phase 3	NCT00799617 Comparator	Nov 2009 → Jul 2014	hypogonadism, male	University of Pennsylvania	Completed	No outcome recorded
Phase 3	NCT00965341 Comparator	Sep 2009 → Sep 2012	cancer of unknown primary site	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 3	NCT00479609 Comparator	Apr 2007 → Jan 2009	metabolic syndrome X	Karolinska Institutet	Unknown	No outcome recorded
Phase 3	NCT00962637 Comparator	Mar 2006 → May 2007	hypogonadotropic hypogonadism	Repros Therapeutics Inc.	Completed	No outcome recorded
Phase 3	NCT00345969 Comparator	Nov 2004 → Feb 2009	hypogonadism	Washington University School of Medicine	Completed	No outcome recorded
Phase 3	NCT00185198 Comparator	Sep 2004 → Sep 2006	hypogonadism	Bayer	Completed	No outcome recorded
Phase 4	NCT06294990 Comparator	Aug 2024 → Dec 2029 expected	Klinefelter syndrome	Lise Aksglæde	Recruiting	No outcome recorded
Phase 4	NCT05484167 Comparator	Jan 2023 → Jan 2024	erectile dysfunction, sexual disorder	University of Utah	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT04439799 Comparator	Aug 2020 → Feb 2023	hypogonadism, male	University of Miami	Completed	No outcome recorded
Phase 4	NCT04456296 Comparator	Jun 2020 → Jul 2023	hypogonadism, male, hypogonadotropic hypogonadism	Endo USA Inc., a Keenova Therapeutics Company	Completed	No outcome recorded
Phase 4	NCT03518034 Comparator	May 2018 → Jan 2023	cardiovascular disorder, hypogonadism, male	AbbVie	Completed	No outcome recorded
Phase 4	NCT02433730 Comparator	May 2015 → Sep 2019	hypogonadotropic hypogonadism	Marianne Andersen	Completed	No outcome recorded
Phase 4	NCT03619330 Comparator	Dec 2014 → Aug 2015	hypogonadism, obesity disorder	University Medical Centre Ljubljana	Completed	No outcome recorded
Phase 4	NCT02366975 Comparator	Nov 2012 → Jan 2017	benign prostatic hyperplasia, hypogonadism, male	University of Florence	Completed	No outcome recorded
Phase 4	NCT01689896 Comparator	Aug 2012 → Mar 2015	hypogonadism, male	Johns Hopkins University	Withdrawn	No outcome recorded
Phase 4	NCT01560546 Comparator	Mar 2012 → May 2013	hypogonadism, type 2 diabetes mellitus	Marianne Andersen	Completed	No outcome recorded
Phase 4	NCT01127659 Comparator	May 2010 → Mar 2015	hypogonadotropic hypogonadism	University at Buffalo	Completed	No outcome recorded
Phase 4	NCT00957801 Comparator	Mar 2009 → Dec 2015	muscular atrophy	The University of Texas Medical Branch, Galveston	Completed	No outcome recorded
Phase 4	NCT01454011 Comparator	Sep 2008 → Feb 2011	hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT01533129 Comparator	Aug 2008 → Apr 2011	hypogonadotropic hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT02171390 Comparator	Aug 2008 → Jun 2012	hypogonadotropic hypogonadism	Gulhane School of Medicine	Completed	No outcome recorded
Phase 4	NCT00700024 Comparator	Apr 2008 → Jan 2010	hypogonadism, male, metabolic syndrome X	Odense University Hospital	Unknown	No outcome recorded
Phase 4	NCT00304746 Comparator	Apr 2006 → Dec 2008	major depressive disorder	Mclean Hospital	Completed	No outcome recorded
Phase 4	NCT00194675 Comparator	Mar 2005 → Apr 2010	benign prostatic hyperplasia, hypogonadism	University of Washington	Completed	No outcome recorded
Phase 4	NCT00190060 Comparator	Oct 2004 → Dec 2008	muscular atrophy	Manchester University NHS Foundation Trust	Completed	No outcome recorded
Phase 4	NCT00287586 Comparator	Sep 2004 → Feb 2012	atherosclerosis, hypogonadism	Brigham and Women's Hospital	Completed	No outcome recorded
—	NCT06720597 Comparator	Aug 2025 → Jan 2027 expected	erectile dysfunction, hypogonadism, male	University of California, Irvine	Recruiting	No outcome recorded
—	NCT02758431 Comparator	Jul 2016 → Jan 2023	hypogonadism	University of Colorado, Denver	Completed	No outcome recorded
—	NCT02549690 Comparator	Sep 2015 → May 2016	infertility disorder	Vietnam National University	Withdrawn	No outcome recorded
—	NCT02269072 Comparator	Feb 2015 → Feb 2016	hypertensive disorder	Massachusetts General Hospital	Withdrawn	No outcome recorded Stop: Business
—	NCT01783574 Comparator	Aug 2013 → Jan 2017	major depressive disorder	Massachusetts General Hospital	Completed	No outcome recorded
—	NCT01377103 Comparator	Jul 2011 → Oct 2012	heart failure, hypogonadism	Cedars-Sinai Medical Center	Withdrawn	No outcome recorded
—	NCT01291212 Comparator	Jan → Jun 2011	—	Hospital Clinic of Barcelona	Unknown	Met primary
—	NCT00494208 Comparator	Jan → Dec 2009	hypogonadism, ovarian disorder	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Completed	No outcome recorded
—	NCT03116087 Comparator	Mar 2007 → May 2018	female stress incontinence	Charles Drew University of Medicine and Science	Completed	No outcome recorded
—	NCT00676676 Comparator	Mar 2007 → Oct 2008	depressive disorder	Massachusetts General Hospital	Completed	No outcome recorded
—	NCT00433173 Comparator	May 2006 → Feb 2011	metabolic syndrome X	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Suspended	No outcome recorded
—	NCT03289559 Comparator	Jan 2006 → Jan 2011	—	University of Colorado, Denver	Completed	No outcome recorded
—	NCT00694733 Comparator	May 2005 → Mar 2024	obesity disorder	Oregon Health and Science University	Unknown	No outcome recorded
—	NCT00095212 Comparator	Sep 2004 → Apr 2008	HIV infectious disease	Massachusetts General Hospital	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 45

Date	Issuer	Release
2025-03-12	Lipocine Inc.	Regulatory Lipocine Announces FDA Labeling Changes for Testosterone Products lipocine.com ↗ Based on the TRAVERSE trial results, the FDA has recommended that the Boxed Warning related to an increased risk of adverse cardiovascular outcomes be removed from the labels of testosterone products.
2021-06-01	Alembic Pharmaceuticals Ltd.	Regulatory 161h June, 2021, Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Final Approval for Testosterone Topical Solution USP, 30 mg per pump actuation.
2021-03-01	Alembic Pharmaceuticals Ltd.	Regulatory 4th March, 2021, Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals announces its joint v·enture Aleor Dermaceuticals receives USFDA Final Approval for Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation).
2020-12-08	Lipocine Inc.	Regulatory Lipocine Announces Tentative Approval of TLANDO™ lipocine.com ↗ We are pleased to have received this tentative approval for TLANDO.
2020-11-06	Lipocine Inc.	Regulatory Lipocine Provides Regulatory Update on TLANDO™ lipocine.com ↗
2020-11-01	Alembic Pharmaceuticals Ltd.	Regulatory 25th November, 2020, Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals announces its joint venture Aleor Dermaceuticals receives USFDA Tentative Approval for Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation).
2020-10-14	Lipocine Inc.	Results Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America lipocine.com ↗ A majority (81%) of hypogonadal subjects achieved average testosterone levels within the normal range post ~3 weeks of treatment without dose adjustment (95% CI 72% - 88%).
2020-09-22	TesoRx Pharma, LLC	Results TesoRx Announces Successful Completion of Confirmative Study of Oral Testosterone Candidate TSX-049 tesorx.com ↗ The results of the study confirmed that the newly optimized TSX-049 formulation candidate has enhanced bioavailability and a dose response sufficient to overcome negative feedback of gonadal testosterone production.
2020-08-28	Lipocine Inc.	Regulatory Lipocine Provides Regulatory Update for TLANDO™ lipocine.com ↗ Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO's New Drug Application ("NDA") and is committed to taking action as expeditiously as possible.
2020-04-21	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Publication of Results from Natesto Spermatogenesis Study in Journal of Urology aytubio.com ↗ The study concluded that Natesto was effective in returning hypogonadal men to back to normal testosterone levels, significantly improve erectile function and quality of life, preserve gonadotropin hormones, and most importantly preserve semen parameters through 6 months of treatment.
2020-04-17	Lipocine Inc.	Regulatory U.S. FDA Denies Clarus's Oral Testosterone Ester Citizen Petition lipocine.com ↗ Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2 , 2019.
2019-11-11	Lipocine Inc.	Regulatory Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA lipocine.com ↗ TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men and received a Complete Response Letter from the U.S. Food and Drug Administration on November 8, 2019 .
2019-10-17	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Positive Clinical Results from Natesto(R) Spermatogenesis Study aytubio.com ↗ This is the first such study to demonstrate conclusively that a testosterone replacement therapy (TRT) maintains key fertility parameters in hypogonadal men.
2019-09-23	Lipocine Inc.	Results Lipocine Announces Presentations at the 20th Annual Fall Meeting of the Sexual Medicine Society of North America lipocine.com ↗ Improved Patient Reported Sexual and Mental Domain Outcomes with Oral Testosterone (TLANDO) Relative to Topical Testosterone in Treated Hypogonadal Men
2019-07-08	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Publication of Clinical Study Results Demonstrating Effectiveness of Natesto(R) Regardless of Patients' Baseline Hypogonadism Severity aytubio.com ↗ Natesto is effective for a wide range of hypogonadal patients regardless of the degree of their baseline hypogonadism.
2019-05-14	Lipocine Inc.	Regulatory Lipocine Announces TLANDO™ NDA PDUFA Action Date of November 9, 2019 lipocine.com ↗ Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has accepted its New Drug Application ("NDA") for TLANDO as testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
2019-04-12	Lupin Limited	Regulatory Lupin launches Testosterone Gel lupin.com ↗ Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced the launch of Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), having received an approval from the United States Food and Drug Administration (FDA).
2019-04-11	Lupin Limited	Regulatory Lupin receives FDA approval for Testosterone Gel lupin.com ↗ Lupin Limited (Lupin) announced that it has received approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie, Inc’s (AbbVie) AndroGel 1.62%.
2019-03-27	Aytu BioPharma, Inc.	Results Aytu BioScience Provides Study Update for Spermatogenesis Study of Natesto (R), the Only FDA-Approved, Nasally-Administered Testosterone Treatment aytubio.com ↗ Interim results published to date demonstrate that all three measured fertility parameters are preserved after three and six months of Natesto treatment.
2019-03-27	Hyundai Pharmaceutical Co., LTD.	Results 매체 hyundaipharm.co.kr ↗ 실제 비염환자를 대상으로 한 임상 시험에서도 대부분 나테스토 사용에 큰 문제가 없었다는 시험 결과를 공개하기도 했다.
2019-03-19	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Two Recent Publications Highlighting Improved Efficacy and Patient Preference of Natesto Nasal Testosterone over Topical Gels aytubio.com ↗ Further, the results confirmed the majority of patients prefer Natesto over topical testosterone gels and had higher levels of treatment satisfaction.
2019-03-12	Lipocine Inc.	Results Lipocine's LPCN 1144 for NASH Demonstrates Substantial Fatty Liver Resolution and Meaningful Liver Fat Reduction in NAFLD Population lipocine.com ↗ Treatment results at End of Study ("EOS") with LPCN 1144 demonstrated that 48% of the treated NAFLD subjects had NAFLD resolution, defined as liver fat <5% post treatment, an improvement over the 28% percent observed after ~8 weeks of treatment.
2018-11-15	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Positive Interim Results from Natesto(R) Spermatogenesis Study aytubio.com ↗ Normal semen parameters, including sperm concentration, sperm motility, and total motile sperm count (TMSC), were maintained at both three months and six months in hypogonadal men taking Natesto three times daily.
2018-11-07	Aytu BioPharma, Inc.	Results Aytu BioScience Reports 55% Sequential Revenue Growth in Q1 FY19; Adds Tuzistra(R) XR to Portfolio aytubio.com ↗ Additionally, initial results this quarter from the Natesto spermatogenesis study indicate that Natesto could be an alternative for the 20% of hypogonadal men wishing to be treated for Low T while preserving their fertility.
2018-09-17	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Publication of Manuscript Summarizing Results from the Ongoing Natesto(R) Spermatogenesis Study aytubio.com ↗ After both three months and six months of Natesto therapy, there were no statistically significant changes in sperm concentration, sperm motility, and total motile sperm count from baseline.
2018-05-03	Aytu BioPharma, Inc.	Results Aytu BioScience Featured in Local ABC News Segment (VIDEO): "UM Doctors Test New Medication for Treating Men with Low Testosterone; Nasal Testosterone Gel doesn't Appear to have Negative Side Effects, Doctors Say." aytubio.com ↗ So far, 12 men have participated in the study and doctors say all of them have had promising results.
2018-04-17	Lupin Limited	Regulatory Lupin receives tentative FDA approval for generic AndroGel®, 1.62% lupin.com ↗ Mumbai, Baltimore: Pharma major Lupin announced that it has received tentative approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie Inc.’s AndroGel®, 1.62%.
2018-03-20	Aytu BioPharma, Inc.	Results Aytu BioScience Presents New Research Findings for Natesto(R) at the Endocrine Society's 100th Annual Meeting aytubio.com ↗ Treatment with Natesto® restored serum testosterone levels to normal levels in hypogonadal men without excursions above the normal range.
2017-10-25	Lupin Limited	Regulatory Lupin receives FDA approval for generic Axiron® topical solution lupin.com ↗
2017-07-17	Perrigo Company	Regulatory Perrigo Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel® Topical Gel, 1.62% Packets perrigo.com ↗ Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing AbbVie Inc.'s Androgel ® Topical Gel, 1.62% packets (20.25 mg/1.25 g packet and 40.5 mg/2.5 g packet).
2017-05-17	Aytu BioPharma, Inc.	Results Aytu BioScience Presents New Research Findings for its Natesto® Testosterone Nasal Gel at 112th American Urological Association Annual Meeting aytubio.com ↗ A podium session was also presented, which demonstrated significant improvement in all domains of erectile function as well as improvement in mood with Natesto therapy.
2017-04-04	Aytu BioPharma, Inc.	Results Aytu BioScience Presents Latest Clinical Findings for Natesto® at ENDO 2017, the National Endocrine Society's Annual Scientific Meeting aytubio.com ↗ Natesto allows men to achieve serum total T levels in the normal range while not increasing hematologic values above the normal range.
2017-03-01	Perrigo Company	Regulatory Perrigo Announces FDA Final Approval For The Generic Version Of Axiron® Topical Solution, 30 mg/1.5 mL perrigo.com ↗ Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application referencing Eli Lilly and Company's Axiron ® Topical Solution, 30 mg/1.5 mL (Testosterone Topical Solution, 30 mg/1.5 mL).
2017-02-01	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Two Presentations at Endocrine Society 2017 Annual Meeting Highlighting Benefits of Natesto® (Testosterone) Nasal Gel in Men aytubio.com ↗ The pharmacokinetics, safety, and efficacy of Natesto for restoring normal testosterone levels in men with Low T is not adversely affected by seasonal allergies.
2017-01-18	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Two Presentations Highlighting Benefits of Natesto® (Testosterone) Nasal Gel in Men at American Urological Association Annual Meeting aytubio.com ↗ Treatment with Natesto restores serum total testosterone to normal levels in hypogonadal men, while also mitigating the decline in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) which remained within the normal range at Day 90 of treatment.
2016-11-30	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Study Findings Demonstrating Clinical Improvements in Erectile Function and Mood in Hypogonadal Men Treated with Natesto® Nasal Testosterone Gel aytubio.com ↗ NTG achieves large, clinical improvements in erectile function and mood within 30 days of initiating treatment, with the added bonus of improvements in sexual desire.
2016-06-28	Aytu BioPharma, Inc.	Results Aytu BioScience Announces Presentation of Clinical Data Highlighting Efficacy of Natesto(TM) (Testosterone) Nasal Gel in Men with Seasonal Allergies aytubio.com ↗
2016-06-08	TesoRx Pharma, LLC	Regulatory FDA grants orphan designation for TesoRx's unmodified Testosterone treatment for Constitutional Delay in Growth in Puberty (CDGP) for boys. tesorx.com ↗
2014-07-24	Perrigo Company	Regulatory Perrigo Confirms AB Therapeutic Equivalent Rating From The FDA For Its Testosterone Gel 1.0% perrigo.com ↗ today announced that it has received an AB therapeutic equivalent rating from the U.S. Food and Drug Administration (FDA) for its previously approved New Drug Application (NDA) for testosterone gel 1.0%.
2013-05-29	Perrigo Company	Regulatory Perrigo Confirms Patent Challenge For Generic Version Of Axiron® Topical Solution perrigo.com ↗ Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for testosterone topical solution, the generic version of Axiron® Topical Solution.
2013-02-19	Perrigo Company	Regulatory Perrigo Confirms First to File Patent Challenge for Generic Version of Testosterone Gel 1.62% perrigo.com ↗ Perrigo Company (Nasdaq: PRGO; TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application for testosterone gel 1.62% and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
2013-02-05	Perrigo Company	Regulatory Perrigo Confirms FDA Approval For Testosterone Gel 1% perrigo.com ↗ Perrigo Company (Nasdaq: PRGO;TASE) announced that it has received U.S. Food and Drug Administration approval for its New Drug Application (NDA) for testosterone gel 1%.
2011-11-02	Perrigo Company	Regulatory Perrigo Confirms Filing for Testosterone Gel 1.0% and Announcement of Patent Infringement Lawsuit by Abbott perrigo.com ↗
2011-06-28	Eli Lilly and Company	Results Newly Published Study Showed Axiron® (testosterone) Topical Solution Restored Testosterone Levels to Normal Range in Hypogonadal Men lilly.com ↗ On Day 120, of the 138 men for which there was evaluable data, 84% had an average testosterone concentration within the normal range (300-1050 ng/dL).
2010-11-23	Eli Lilly and Company	Regulatory Lilly and Acrux Receive FDA Approval for Axiron® (Testosterone) Topical Solution CIII lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Acrux (ASX: ACR) announced that the U.S. Food and Drug Administration (FDA) has approved Axiron® (testosterone) topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone.

All press releases naming this drug 84 releases

Date	Issuer	Release
2026-10-07	Lipocine Inc.	Lipocine Announces Health Canada Approval of TLANDO® for Testosterone Replacement Therapy lipocine.com ↗
2025-03-12	Lipocine Inc.	Lipocine Announces FDA Labeling Changes for Testosterone Products lipocine.com ↗
2022-06-07	Halozyme Therapeutics	Halozyme Announces Commercial Launch of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy halozyme.com ↗
2021-06-01	Alembic Pharmaceuticals Ltd.	161h June, 2021, Vadodara, India alembicpharmaceuticals.com ↗
2021-03-01	Alembic Pharmaceuticals Ltd.	4th March, 2021, Vadodara, India alembicpharmaceuticals.com ↗
2020-12-08	Lipocine Inc.	Lipocine Announces Tentative Approval of TLANDO™ lipocine.com ↗
2020-11-06	Lipocine Inc.	Lipocine Provides Regulatory Update on TLANDO™ lipocine.com ↗
2020-11-01	Alembic Pharmaceuticals Ltd.	25th November, 2020, Vadodara, India alembicpharmaceuticals.com ↗
2020-10-14	Lipocine Inc.	Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America lipocine.com ↗
2020-09-22	TesoRx Pharma, LLC	TesoRx Announces Successful Completion of Confirmative Study of Oral Testosterone Candidate TSX-049 tesorx.com ↗
2020-08-28	Lipocine Inc.	Lipocine Provides Regulatory Update for TLANDO™ lipocine.com ↗
2020-08-14	Xiromed LLC	Xiromed LLC Announces the Launch of Testosterone Gel 1.62% Metered Dose Pump (20.25mg/1.25g pump actuation), AB-Rated Generic to AndroGel® 1.62% xiromed.com ↗
2020-07-20	Aytu BioPharma, Inc.	Aytu BioScience Announces Expansion of NATESTO(R) U.S. Commercial Team aytubio.com ↗
2020-06-03	Aytu BioPharma, Inc.	Aytu BioScience Announces Significant Improvement in Natesto(R) Patient Access in the United States aytubio.com ↗
2020-04-21	Aytu BioPharma, Inc.	Aytu BioScience Announces Publication of Results from Natesto Spermatogenesis Study in Journal of Urology aytubio.com ↗
2020-04-17	Lipocine Inc.	U.S. FDA Denies Clarus's Oral Testosterone Ester Citizen Petition lipocine.com ↗
2020-02-05	Aytu BioPharma, Inc.	Aytu BioScience Announces Acceptance of Results of Two Natesto Clinical Studies for Presentation at American Urological Association Annual Scientific Program aytubio.com ↗
2019-12-02	Aytu BioPharma, Inc.	Aytu BioScience Announces Launch of Natesto(R) U.S. Co-Promotion with Acerus Pharmaceuticals aytubio.com ↗
2019-11-11	Lipocine Inc.	Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA lipocine.com ↗
2019-10-17	Aytu BioPharma, Inc.	Aytu BioScience Announces Positive Clinical Results from Natesto(R) Spermatogenesis Study aytubio.com ↗
2019-10-16	Aytu BioPharma, Inc.	Aytu BioScience to Announce Results from Natesto(R) Spermatogenesis Study on Thursday, October 17 aytubio.com ↗
2019-09-24	Aytu BioPharma, Inc.	Aytu BioScience Announces Addition of Natesto(R) to Leading National Pharmacy Benefit Manager's Formulary; Natesto Added to Commercial Plans Covering Over 30 Million U.S. Lives aytubio.com ↗
2019-09-23	Lipocine Inc.	Lipocine Announces Presentations at the 20th Annual Fall Meeting of the Sexual Medicine Society of North America lipocine.com ↗
2019-08-01	Aytu BioPharma, Inc.	Natesto Spermatogenesis Study Final Results Accepted for Presentation at 'Late-Breaking' Session at the American Society for Reproductive Medicine 75th Annual Scientific Conference aytubio.com ↗
2019-07-30	Aytu BioPharma, Inc.	Acerus And Aytu Bioscience To Co-Promote NATESTO® In The United States aytubio.com ↗
2019-07-30	Aytu BioPharma, Inc.	Aytu BioScience Expands Natesto(R) Partnership with Acerus Pharmaceuticals to Accelerate Natesto Growth in the U.S. aytubio.com ↗
2019-07-24	Aytu BioPharma, Inc.	Natesto(R) Added to National Pharmacy Benefit Manager's Formulary Natesto Now Covered on Payer Plans Covering Over 6 Million U.S. Lives aytubio.com ↗
2019-07-08	Aytu BioPharma, Inc.	Aytu BioScience Announces Publication of Clinical Study Results Demonstrating Effectiveness of Natesto(R) Regardless of Patients' Baseline Hypogonadism Severity aytubio.com ↗
2019-06-12	Aytu BioPharma, Inc.	Aytu BioScience Featured in Local NBC News Segment (VIDEO): ''Nasal Spray for Low Testosterone Preserves Fertility'' aytubio.com ↗
2019-05-14	Lipocine Inc.	Lipocine Announces TLANDO™ NDA PDUFA Action Date of November 9, 2019 lipocine.com ↗
2019-04-12	Lupin Limited	Lupin launches Testosterone Gel lupin.com ↗
2019-04-11	Lupin Limited	Lupin receives FDA approval for Testosterone Gel lupin.com ↗
2019-04-11	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Launch of a Generic Version of AndroGel® (testosterone gel) 1.62% CIII in the United States tevapharm.com ↗
2019-04-03	Lipocine Inc.	Lipocine Seeks Injunction Against the Marketing of Clarus Therapeutics' JATENZO® for Testosterone Replacement Therapy lipocine.com ↗
2019-03-27	Lipocine Inc.	Lipocine Announces ABPM Labeling Study Results Consistent with Recently Approved Testosterone Replacement Therapy lipocine.com ↗
2019-03-27	Aytu BioPharma, Inc.	Aytu BioScience Provides Study Update for Spermatogenesis Study of Natesto (R), the Only FDA-Approved, Nasally-Administered Testosterone Treatment aytubio.com ↗
2019-03-27	Hyundai Pharmaceutical Co., LTD.	매체 hyundaipharm.co.kr ↗
2019-03-19	Aytu BioPharma, Inc.	Aytu BioScience Announces Two Recent Publications Highlighting Improved Efficacy and Patient Preference of Natesto Nasal Testosterone over Topical Gels aytubio.com ↗
2019-03-14	Aytu BioPharma, Inc.	Aytu BioScience Announces Natesto(R) Presentations at Two Upcoming Scientific Conferences aytubio.com ↗
2019-03-12	Lipocine Inc.	Lipocine's LPCN 1144 for NASH Demonstrates Substantial Fatty Liver Resolution and Meaningful Liver Fat Reduction in NAFLD Population lipocine.com ↗
2019-01-10	Aytu BioPharma, Inc.	Aytu BioScience Provides Natesto(R) Commercial Update for the Quarter Ending December 31, 2018, Reports 27% Prescription Growth and Expansion of Natesto(R) Direct Program aytubio.com ↗
2018-11-15	Aytu BioPharma, Inc.	Aytu BioScience Announces Positive Interim Results from Natesto(R) Spermatogenesis Study aytubio.com ↗
2018-11-13	Aytu BioPharma, Inc.	Aytu BioScience to Report Interim Results from Natesto(R) Spermatogenesis Study on Thursday, November 15, 2018 aytubio.com ↗
2018-11-07	Aytu BioPharma, Inc.	Aytu BioScience Reports 55% Sequential Revenue Growth in Q1 FY19; Adds Tuzistra(R) XR to Portfolio aytubio.com ↗
2018-10-15	Perrigo Company	Perrigo Announces The Launch Of An AB Rated Generic Version Of Androgel® Topical Gel, 1.62% perrigo.com ↗
2018-09-17	Aytu BioPharma, Inc.	Aytu BioScience Announces Publication of Manuscript Summarizing Results from the Ongoing Natesto(R) Spermatogenesis Study aytubio.com ↗
2018-09-06	Aytu BioPharma, Inc.	Natesto(R) Q4 Revenue Increases 178% Sequentially; Q4 Product Revenue Increases 52% Sequentially aytubio.com ↗
2018-07-17	Aytu BioPharma, Inc.	Aytu BioScience Announces Enrollment of First Twenty Patients in the Natesto(R) Spermatogenesis Study aytubio.com ↗
2018-05-03	Aytu BioPharma, Inc.	Aytu BioScience Featured in Local ABC News Segment (VIDEO): "UM Doctors Test New Medication for Treating Men with Low Testosterone; Nasal Testosterone Gel doesn't Appear to have Negative Side Effects, Doctors Say." aytubio.com ↗
2018-04-17	Lupin Limited	Lupin receives tentative FDA approval for generic AndroGel®, 1.62% lupin.com ↗
2018-03-20	Aytu BioPharma, Inc.	Aytu BioScience Presents New Research Findings for Natesto(R) at the Endocrine Society's 100th Annual Meeting aytubio.com ↗
2018-02-25	Lupin Limited	Lupin launches generic Axiron® topical solution in the US lupin.com ↗
2018-02-21	Aytu BioPharma, Inc.	Aytu BioScience Provides Update on the Continued Growth of Natesto® in the U.S. aytubio.com ↗
2018-01-10	Lipocine Inc.	Lipocine Announces Outcome of FDA Advisory Committee Meeting for TLANDO™, Testosterone Replacement Therapy in Adult Males with Hypogonadism lipocine.com ↗
2017-11-28	Aytu BioPharma, Inc.	Aytu BioScience Provides Update on the Continued Growth of Natesto® in the U.S. aytubio.com ↗
2017-10-26	Aytu BioPharma, Inc.	Aytu BioScience Provides Quarterly Update on the Natesto® U.S. Launch aytubio.com ↗
2017-10-25	Lupin Limited	Lupin receives FDA approval for generic Axiron® topical solution lupin.com ↗
2017-09-26	Aytu BioPharma, Inc.	Aytu BioScience Provides Update on the Natesto® U.S. Launch aytubio.com ↗
2017-08-18	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Exclusive Launch of Generic Axiron® in the United States tevapharm.com ↗
2017-07-17	Perrigo Company	Perrigo Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel® Topical Gel, 1.62% Packets perrigo.com ↗
2017-07-05	Perrigo Company	Perrigo Launches The Generic Version Of Axiron® Topical Solution perrigo.com ↗
2017-05-17	Aytu BioPharma, Inc.	Aytu BioScience Presents New Research Findings for its Natesto® Testosterone Nasal Gel at 112th American Urological Association Annual Meeting aytubio.com ↗
2017-04-04	Aytu BioPharma, Inc.	Aytu BioScience Presents Latest Clinical Findings for Natesto® at ENDO 2017, the National Endocrine Society's Annual Scientific Meeting aytubio.com ↗
2017-03-01	Perrigo Company	Perrigo Announces FDA Final Approval For The Generic Version Of Axiron® Topical Solution, 30 mg/1.5 mL perrigo.com ↗
2017-02-22	Aytu BioPharma, Inc.	Aytu BioScience Announces Expansion of U.S. Sales Team to Support Increasing Growth of Natesto Prescriptions and Revenues aytubio.com ↗
2017-02-01	Aytu BioPharma, Inc.	Aytu BioScience Announces Two Presentations at Endocrine Society 2017 Annual Meeting Highlighting Benefits of Natesto® (Testosterone) Nasal Gel in Men aytubio.com ↗
2017-01-18	Aytu BioPharma, Inc.	Aytu BioScience Announces Two Presentations Highlighting Benefits of Natesto® (Testosterone) Nasal Gel in Men at American Urological Association Annual Meeting aytubio.com ↗
2016-11-30	Aytu BioPharma, Inc.	Aytu BioScience Announces Study Findings Demonstrating Clinical Improvements in Erectile Function and Mood in Hypogonadal Men Treated with Natesto® Nasal Testosterone Gel aytubio.com ↗
2016-07-06	Aytu BioPharma, Inc.	Aytu BioScience Provides Update on Natesto Product Launch aytubio.com ↗
2016-06-30	Aytu BioPharma, Inc.	Aytu BioScience to Host Conference Call to Detail Company's Natesto® U.S. Launch Plans aytubio.com ↗
2016-06-28	Aytu BioPharma, Inc.	Aytu BioScience Announces Presentation of Clinical Data Highlighting Efficacy of Natesto(TM) (Testosterone) Nasal Gel in Men with Seasonal Allergies aytubio.com ↗
2016-06-08	TesoRx Pharma, LLC	FDA grants orphan designation for TesoRx's unmodified Testosterone treatment for Constitutional Delay in Growth in Puberty (CDGP) for boys. tesorx.com ↗
2016-05-18	Aytu BioPharma, Inc.	Aytu BioScience Initiates Commercial Expansion to Support July 2016 Launch of Natesto® aytubio.com ↗
2016-04-25	Aytu BioPharma, Inc.	Aytu BioScience Enters $2 Billion Testosterone Replacement Market with Acquisition of U.S. Commercial Rights to Natesto® aytubio.com ↗
2015-01-12	Perrigo Company	Perrigo Launches AB Therapeutic Equivalent Testosterone Gel 1.0% perrigo.com ↗
2014-07-24	Perrigo Company	Perrigo Confirms AB Therapeutic Equivalent Rating From The FDA For Its Testosterone Gel 1.0% perrigo.com ↗
2013-05-29	Perrigo Company	Perrigo Confirms Patent Challenge For Generic Version Of Axiron® Topical Solution perrigo.com ↗
2013-02-19	Perrigo Company	Perrigo Confirms First to File Patent Challenge for Generic Version of Testosterone Gel 1.62% perrigo.com ↗
2013-02-05	Perrigo Company	Perrigo Confirms FDA Approval For Testosterone Gel 1% perrigo.com ↗
2011-11-02	Perrigo Company	Perrigo Confirms Filing for Testosterone Gel 1.0% and Announcement of Patent Infringement Lawsuit by Abbott perrigo.com ↗
2011-06-28	Eli Lilly and Company	Newly Published Study Showed Axiron® (testosterone) Topical Solution Restored Testosterone Levels to Normal Range in Hypogonadal Men lilly.com ↗
2011-04-01	Eli Lilly and Company	Axiron® (Testosterone) Topical Solution CIII Now Available in Pharmacies lilly.com ↗
2010-11-23	Eli Lilly and Company	Lilly and Acrux Receive FDA Approval for Axiron® (Testosterone) Topical Solution CIII lilly.com ↗
2010-03-15	Eli Lilly and Company	Lilly to Acquire Global License to AXIRON Testosterone Solution From Acrux lilly.com ↗

Evidence & citations 42 cited values

Every value below carries the sentence it was read from. 311 sources stand behind the page.

Field	Value	Cited text
Known as	testostérone	“4 years of follow up (FU) with evaluation at T0 (14 years old +/- 6 months), T1 (16 years old +/-6 months) and T2 (18 years old+/- 6 months) with eather ANDROGEL® 16.2 mg/g,...” NCT06351501 ↗ 284 “Drug name: Sustanon 250 Generic Name: Testosterone Proprietary Name: N/A Formulation: 250mg of Testosterone in 1ml volume Dose: 250mg of testosterone Frequency: every 2 weeks...” NCT03054168 ↗ “Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream...” NCT04807894 ↗ “This clinical trial will investigate the potential benefit of precise testosterone replacement for ameliorating priapism and improving psychological well-being in hypogonadal...” NCT01940718 ↗ “Transdermal gel testosterone is the preferred route of administration for achieving steady serum testosterone concentrations as compared to oral and intramuscular formulations.” NCT05825092 ↗ “Atrophic subtype support may include: estradiol, progesterone, testosterone, DHEA, pregnenolone, levothyroxine, liothyronine, hydrocortisone.” NCT05894954 ↗ “Study drug is Androgel® 1.62 mg/L approved by the ANSM for the treatment of hypogonadism in men containing 1.62% of testosterone.” NCT03678233 ↗ “treated for 16 weeks with once-daily testosterone gel treatment (starting dose, 40.5 mg/day; min, max dose, 20.25, 81.0 mg/day)” PMID 39385523 ↗ Oct 2024 “Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and aromatase inhibitor months 4-8.” NCT00694733 ↗ “Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism” NCT01107067 ↗ “DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men.” NCT02966652 ↗ Show 274 more sources
Known as	Andro-Feme	“Testosterone cream 1% (Andro-Feme® )” NCT03210558 ↗
Known as	Androderm	“Testosterone Transdermal System (Androderm 5 mg patch)” NCT00266864 ↗ 1 NCT04320745 ↗
Known as	AndroFeme 1(testosterone 1% w/v cream)	“AndroFeme 1(testosterone 1% w/v cream)” NCT01783574 ↗
Known as	AndroGel	“4 years of follow up (FU) with evaluation at T0 (14 years old +/- 6 months), T1 (16 years old +/-6 months) and T2 (18 years old+/- 6 months) with eather ANDROGEL® 16.2 mg/g,...” NCT06351501 ↗ 27 “Test product. The products given during this study are licensed under the names of Cialis (tadalafil) and Androgel and Testogel (testosterone gel).” NCT00244023 ↗ “Participants will be randomised to treatment with transdermal placebo or transdermal testosterone (Androgel; Besins Healthcare, Paris, France)” PMID 40090688 ↗ Mar 2025 “Testosterone 7.5 g gel (AndroGel) transdermally daily” NCT00438321 ↗ “Androgel (50mg testosterone), gel, daily” NCT03176537 ↗ “testosterone 50 mg topic gel (Androgel)” NCT03281187 ↗ “AndroGel 5G topical testosterone” NCT01386606 ↗ “Testosterone gel (AndroGel 5g)” NCT06455969 ↗ “AndroGel® (testosterone gel)” NCT00799617 ↗ “AndroGel (testosterone gel)” NCT00351819 ↗ “Testosterone Gel (Androgel)” NCT00287586 ↗ Show 17 more sources
Known as	AndroGel 1.62	“1.62% topical testosterone gel (AndroGel 1.62%; AbbVie).” PMID 39252657 ↗ Sep 2024
Known as	Axiron	“Axiron Testosterone Topical Solution” NCT02722278 ↗
Known as	BAYV001915	“Testogel (Testosterone, BAYV001915)” NCT00185198 ↗
Known as	DITEST	“DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men.” NCT02966652 ↗
Known as	FE 99903	“Testosterone gel (FE 99903)” NCT01370369 ↗
Known as	FE 999093	“Testosterone Gel (FE 999093)” NCT01703741 ↗
Known as	FE 999303	“Testosterone gel (FE 999303)” NCT01665599 ↗ 2 “Testosterone Gel (FE 999303)” NCT01464879 ↗ “FE 999303 (Testosterone gel)” NCT02149264 ↗
Known as	Fortesta	“Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying...” NCT01228071 ↗ 1 “Testosterone Gel (Fortesta) 40mg daily.” NCT01460654 ↗
Known as	Intrinsa	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01096329 ↗
Known as	MPP10	“MPP10, testosterone” NCT00705796 ↗
Known as	Nasotestt	“testosterone 5 mg nasal gel (Nasotestt)” NCT03281187 ↗
Known as	Natesto	“receiving Testosterone Nasal Gel [Natesto] - Single dose of 5.5 mg Natesto on Day 1 and a single dose of 11 mg Natesto on Day 2” NCT03345797 ↗ 5 “Natesto™ is a testosterone nasal gel that is FDA approved to treat low testosterone.” NCT05484167 ↗ “Natesto™ , a novel testosterone nasal gel, normalizes androgen levels in” PMID 26695758 ↗ Dec 2015 “Natesto is a nasally administered exogenous 4.5% testosterone gel” NCT04717362 ↗ “Drug: NatestoTM” NCT05381831 ↗ NCT04976595 ↗
Known as	NatestoTM	“Drug: NatestoTM” NCT05381831 ↗
Known as	Sustanon 250	“Drug name: Sustanon 250 Generic Name: Testosterone Proprietary Name: N/A Formulation: 250mg of Testosterone in 1ml volume Dose: 250mg of testosterone Frequency: every 2 weeks...” NCT03054168 ↗
Known as	Sustanon-	“Sustanon- intramuscular testosterone 200mg every 2 weeks” NCT00355537 ↗ 1 “Sustanon (testosterone)” NCT07568574 ↗
Known as	T-gel	“Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.” NCT00891228 ↗ 1 “This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin.” NCT01689896 ↗
Known as	Testim	“The product under investigation is testosterone gel, transdermal administration, 50 mg / single dose (Testim®, Ferring, Madrid, Spain).” NCT03378713 ↗ 7 “Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.” NCT00645658 ↗ “Testim 1% (testosterone gel)” NCT00254553 ↗ NCT00700024 ↗ NCT00848497 ↗ NCT01386567 ↗ NCT04456296 ↗ NCT00706719 ↗
Known as	Testogel	“Test product. The products given during this study are licensed under the names of Cialis (tadalafil) and Androgel and Testogel (testosterone gel).” NCT00244023 ↗ 2 “Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo” NCT00613288 ↗ “Testogel (Testosterone, BAYV001915)” NCT00185198 ↗
Known as	Testojel	“Testosteron gel (Testojel 50 mg)” NCT01601327 ↗
Known as	Testopel	“Participants in this group will receive a one-time subcutaneous testosterone insertion of 10 x 75 mg pellets of Testopel for a total of 750 mg Testopel.” NCT04523480 ↗
Known as	Testosteron	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01160341 ↗
Known as	Testosteron Gel Wolff	“The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff (TGW).” NCT00204269 ↗
Known as	Testosterone (NEBIDO)	“Testosterone (NEBIDO)” NCT01084369 ↗
Known as	Testosterone Gel	“Drug: Androgel (Testosterone Gel)” NCT00104572 ↗ 1 “Androgel (Testosterone Gel)” NCT01201863 ↗
Known as	testosterone matrix transdermal system	“Watson's testosterone matrix transdermal system (TMTS)” NCT01323140 ↗
Known as	Testosterone MD-Lotion	“Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.” NCT00857961 ↗ 3 “Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.” NCT00372008 ↗ “Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion” NCT00857168 ↗ “Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion” NCT00857454 ↗
Known as	Testosterone patches	“Testosterone patches” NCT03116087 ↗
Known as	Testosterone Transdermal System	“Watson's testosterone transdermal system delivers male sex hormone through skin” NCT01323140 ↗ 1 “Drug: Testosterone Transdermal System” NCT00338312 ↗
Known as	Testosterone, Transdermal, Behavior	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02215434 ↗
Known as	TGW	“The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff (TGW).” NCT00204269 ↗
Known as	TMTS	“Watson's testosterone matrix transdermal system (TMTS)” NCT01323140 ↗
Known as	Transdermal Androgel	“Transdermal Androgel 1.62% (20.25 mg testosterone = 1 pump actuations) to be applied once daily for 3.5 months.” NCT01940718 ↗
Known as	Vogelxo	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04558567 ↗
Action	Restore	“Clinical practice guidelines recommend testosterone replacement therapy (TRT) for men with sexual dysfunction and testosterone deficiency.” PMID 38224135 ↗ Jan 2024
Modality	Small molecule	“Testosterone is the principal male sex hormone and an anabolic (muscle promoting) steroid.” NCT01595581 ↗
Route	Intramuscular	“Patients receive testosterone intramuscularly (IM)” NCT00006129 ↗
Target	IL6	“TRT exerts an anti-inflammatory role inhibiting interleukins (IL), in particular the IL-6 gene (14)” NCT01123278 ↗