Drugs / Testosterone Undecanoate
Testosterone Undecanoate
also known as
Nebido · AVEED · Jatenzo · LPCN 1021 · testosteron undecanoate · TLANDO · ABT-SLV361 · Andriol · +11 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AVEED | — | 2014-03-05 | fda.gov ↗ |
Trials 56 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06312761 | Jun 2024 → Dec 2025 | hypogonadism, male | University of Washington | Unknown | No outcome recorded |
| Phase 1/2 | NCT03335254 | Nov 2017 → May 2018 | hypogonadism, male | TesoRx Pharma, LLC | Terminated | No outcome recorded |
| Phase 220 trials | ||||||
| Phase 2 | NCT06082817 | Jan → Dec 2025 overdue | hypoactive sexual desire disorder | San Diego Sexual Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05249634 | Mar 2022 → Jun 2028 expected | chronic kidney disease, hypogonadism, male | St. Louis University | Recruiting | No outcome recorded |
| Phase 2 | NCT05081193 | Mar 2022 → Aug 2025 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT04798469 | Jan 2022 → Sep 2027 expected | hypogonadism, male, substance-related disorder | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04049331 | Mar 2021 → Jan 2027 expected | hypogonadism, male, myalgic encephalomeyelitis/chronic fatigue syndrome | Seattle Institute for Biomedical and Clinical Research | Recruiting | No outcome recorded |
| Phase 2 | NCT04685993 | Nov 2020 → Mar 2022 | metabolic dysfunction-associated steatohepatitis | Lipocine Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03910738 | Oct 2019 → Dec 2027 expected | relapsing-remitting multiple sclerosis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 2 | NCT04134091 | Aug 2019 → Jun 2021 | metabolic dysfunction-associated steatohepatitis | Lipocine Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03576001 | Aug 2019 → Jan 2025 | spinal cord injury | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02921386 | Oct 2016 → Jan 2017 | hypogonadism | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03379012 | Feb 2016 → Jan 2018 | renal cell carcinoma | Kidney Cancer Research Bureau | Completed | No outcome recorded |
| Phase 2 | NCT01919294 | Jul 2013 → Jan 2017 | hypogonadism, male, metabolic dysfunction-associated steatohepatitis | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT01724658 | Jun 2012 → Apr 2013 | sexual disorder | Chulalongkorn University | Completed | No outcome recorded |
| Phase 2 | NCT01516554 | Feb 2012 → Jan 2014 | multiple sclerosis | Health Sciences Centre, Winnipeg, Manitoba | Terminated | No outcome recorded |
| Phase 2 | NCT00924612 | Jul → Sep 2009 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00911586 | Jul → Sep 2009 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00695110 | Jun → Dec 2008 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02697188 | Nov 2007 → Apr 2008 | hypogonadism | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00239590 | Jun 2001 → Apr 2004 | coronary artery disorder | Imperial College London | Completed | No outcome recorded |
| Phase 2 | NCT00452322 | Apr 1997 → Jan 2007 | hypogonadism, male | University Hospital Muenster | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05964920 | Sep 2024 → Dec 2025 | hypogonadism, male | Norwegian School of Sport Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT04456530 | May 2020 → Dec 2021 | muscular atrophy | The Stone Research Foundation for Sports Medicine and Arthritis | Unknown | No outcome recorded |
| Phase 2/3 | NCT01206270 | Jun 2009 → Jun 2017 | Klinefelter syndrome, hypogonadism, spermatogenic failure | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT03198728 | Jul 2017 → May 2020 | hypogonadism, male | Marius Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03242408 | Jan → May 2017 | hypogonadism, male | Lipocine Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03242590 | Dec 2016 → Mar 2017 | hypogonadism, male | Lipocine Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02722278 | Mar → Nov 2016 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02081300 | Feb 2014 → May 2015 | hypogonadism, male | Lipocine Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02514629 | Jul 2013 → Jul 2016 | hypogonadism, obesity disorder | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Completed | No outcome recorded |
| Phase 3 | NCT01765179 | Jan → Jul 2013 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01699178 | Aug 2012 → Apr 2014 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01403116 | Jul 2011 → Sep 2013 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00467870 | Mar 2006 → Jul 2009 | hypogonadism, male | Endo USA Inc., a Keenova Therapeutics Company | Completed | No outcome recorded |
| Phase 3 | NCT00146146 | May 2005 → May 2006 | — | Unita Complessa di Ostetricia e Ginecologia | Completed | No outcome recorded |
| Phase 3 | NCT00117000 | Jul 2003 → Feb 2007 | protein-energy malnutrition | University of Adelaide | Unknown | No outcome recorded |
| Phase 3 | NCT00230984 | Apr 2003 → Jun 2008 | nutritional deficiency disease, respiratory failure | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 3 | NCT00220298 | Feb 2003 → Oct 2007 | hypogonadism, male | Bayer | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT06385509 | May 2024 → Nov 2025 overdue | hypogonadism, male | Tolmar Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04983940 | Jun 2021 → Apr 2023 | hypogonadism, male | University of Miami | Completed | No outcome recorded |
| Phase 4 | NCT04120363 | Sep 2019 → Jul 2021 | — | Pennington Biomedical Research Center | Completed | No outcome recorded |
| Phase 4 | NCT03815331 | Jan 2019 → Dec 2020 | Peyronie disease | Men's Health Boston | Completed | No outcome recorded |
| Phase 4 | NCT03126656 | Sep 2016 → Apr 2017 | heart failure, hypogonadism | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 4 | NCT01092858 | Sep 2010 → Jul 2011 | hypogonadism, male | Bayer | Terminated | No outcome recorded |
| Phase 4 | NCT01065220 | Feb 2010 → Jan 2014 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT01852994 | Jul 2009 → Jul 2015 | heart failure | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00710827 | Oct 2008 | hypogonadism | Bayer | Withdrawn | No outcome recorded |
| Phase 4 | NCT00555087 | May 2007 → Jan 2008 | erectile dysfunction, hypogonadotropic hypogonadism | Hospital Santa Fe | Unknown | No outcome recorded |
| Phase 4 | NCT00421460 | Jan 2007 → Jan 2011 | erectile dysfunction, hypogonadism | Chulalongkorn University | Completed | No outcome recorded |
| Phase 4 | NCT00131183 | Sep 2005 → May 2008 | — | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06188767 | Apr 2025 → Dec 2027 expected | — | Morten Hostrup, PhD | Recruiting | No outcome recorded |
| — | NCT05649605 | Mar 2023 → Dec 2025 overdue | — | Karolinska University Hospital | Recruiting | No outcome recorded |
| — | NCT03995251 | Jul 2019 → Jun 2020 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT05417035 | Jun 2014 → Aug 2019 | delayed puberty, self-limited | NU-Hospital Organization, Sweden | Completed | No outcome recorded |
| — | NCT00119483 | Sep 2005 → Dec 2007 | hypogonadism, male | University Hospital of North Norway | Completed | No outcome recorded |
Also used as a comparator or background therapy in 18 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03973840 Background | Jul 2018 | hypogonadism, male | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02966652 Comparator | Nov 2016 → Oct 2018 | hypogonadism, male | Neurocrine UK Limited | Completed | No outcome recorded |
| Phase 1 | NCT01346319 Comparator | Apr → Sep 2011 | hypogonadism, male | Abbott | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02670343 Background | Jan → Mar 2016 | hypogonadism | Clarus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07512323 Comparator | Aug 2026 → Sep 2029 expected | hypogonadism, male | Rune Skovgaard Rasmussen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT00842751 Comparator | Jul → Nov 2009 | — | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00403793 Comparator | Oct 2003 → Dec 2006 | — | Organon and Co | Completed | No outcome recorded |
| Phase 2 | NCT00434824 Comparator | Nov 2001 → Jul 2004 | hypogonadism | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00613782 Comparator | Jan 2009 → Jan 2014 | hypogonadism, type 2 diabetes mellitus | Austin Health | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06489457 Comparator | Sep 2020 → May 2023 | hypogonadism, obesity disorder, type 2 diabetes mellitus | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 3 | NCT04545450 Comparator | Nov 2008 → Jul 2009 | hypogonadism | Unita Complessa di Ostetricia e Ginecologia | Completed | No outcome recorded |
| Phase 3 | NCT00696748 Comparator | Oct 2005 → Jan 2009 | hypogonadism, male, metabolic syndrome X | Russian Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT03851627 Comparator | Jan 2022 → Sep 2028 expected | fatty liver disease, hypogonadism, male, obesity disorder, type 2 diabetes mellitus | Alexandra Kautzky-Willer | Recruiting | No outcome recorded |
| Phase 4 | NCT03721497 Comparator | Dec 2020 → Dec 2025 overdue | hypogonadism, male, muscular atrophy | Esbjerg Hospital - University Hospital of Southern Denmark | Active not recruiting | 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 | NCT03792321 Comparator | Jan 2014 → Mar 2015 | hypogonadism, male, obesity disorder, type 2 diabetes mellitus | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT01813201 Comparator | Mar 2011 → Mar 2014 | heart failure | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04134130 Background | Sep → Dec 2019 | prostate cancer | Lund University | Completed | No outcome recorded |
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 78 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Testosterone Undecanoate | “Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according...” NCT03995251 ↗60“Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as 225 mg testosterone undecanoate twice daily (BID).” NCT04134091 ↗ “Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively” NCT01092858 ↗ “Subjects received 225 mg of oral testosterone undecanoate (TLANDO) twice a day for 24 days without dose adjustment.” PMID 34994093 ↗ Jan 2022 “TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.” NCT03335254 ↗ “Cross-sex hormone therapy consisting of intramuscular injection of testosterone undecanoate 250mg/ml.” NCT05649605 ↗ “intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma)” NCT00613782 ↗ “Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day” NCT03242408 ↗ “Testosterone Undecanoate (TU)200mg twice daily, orally for 7 days” NCT00842751 ↗ “oral preparation of testosterone undecanoate (TU)” NCT03198728 ↗ “Testosterone Undecanoate (ABT-SLV361)” NCT01346319 ↗ “Nebido (Testosterone Undecanoate)” NCT07512323 ↗ “Drug: Testosterone Undecanoate” NCT03851627 ↗ |
| Known as | ABT-SLV361 | “Testosterone Undecanoate (ABT-SLV361)” NCT01346319 ↗ |
| Known as | Andriol | “Oral testosterone undecanoate (Andriol)” NCT00434824 ↗ |
| Known as | AVEED | “Aveed® is an FDA-approved medication for treatment of hypogonadism (low testosterone).” NCT03815331 ↗4“Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]” NCT04049331 ↗ |
| Known as | BAY86-5037 | “Testosterone Undeconate (Nebido, BAY86-5037)” NCT01092858 ↗ |
| Known as | Jatenzo | “oral testosterone undecanoate (oral TU; JATENZO)” PMID 36272969 ↗ Oct 2022 |
| Known as | LPCN 1021 | “Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day” NCT03242408 ↗2“Oral Testosterone Undecanoate (TU, LPCN 1021)” NCT03242590 ↗ “Oral testosterone undecanoate, LPCN 1021” NCT02081300 ↗ |
| Known as | LPCN 1144 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04685993 ↗ |
| Known as | Nebido | “Inj. Testosterone undecanoat (Nebido®), 1000 mg im or placebo preoperative (baseline, weeks 6, 18 and 30 depending on time to surgery) and postoperative (weeks 4, 16, 28, 40) (Table 1).” NCT03721497 ↗9“Testosterone undecanoate (Nebido®) 1,000 mg (4 ml) intramuscular deeply, once before targeted therapy (sunitinib 50 mg 4/2 or pazopanib 800 mg daily)” NCT03379012 ↗ “Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection” NCT03910738 ↗ “Nebido (testosterone undecanoate) intramuscular 4 ml by scheme” NCT00696748 ↗ “Testosterone Undeconate (Nebido, BAY86-5037)” NCT01092858 ↗ “Nebido (Testosterone Undecanoate)” NCT00119483 ↗ |
| Known as | Nebido (3-oxandrostenderivate), testosterone undecanoate | “Nebido (3-oxandrostenderivate), testosterone undecanoate” NCT05649605 ↗ |
| Known as | NebidoTM | “Testosterone undecanoate (TU) - NebidoTM” NCT00220298 ↗ |
| Known as | Oral testosterone undecanoate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01403116 ↗ |
| Known as | Oral TU | “Oral TU” NCT01699178 ↗ |
| Known as | Reandron 1000 | “intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma)” NCT00613782 ↗ |
| Known as | Testolactone undecanoate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01065220 ↗ |
| Known as | testosteron undecanoate | “Active treatment is Nebido, 1000 mg testosteron undecanoate, a 4 ml intramuscular depot injection.” NCT00119483 ↗1“Contraindications Testosteron undecanoate (ATC-code G03BA03)” NCT03721497 ↗ |
| Known as | Testosterone Undeconate | “Testosterone Undeconate (Nebido, BAY86-5037)” NCT01092858 ↗ |
| Known as | Testosterone Undecylate | “Application quarterly of Testosterone Undecylate” NCT01852994 ↗ |
| Known as | Testosterone Undecylate (Nebido) | “Testosterone Undecylate (Nebido)” NCT01852994 ↗ |
| Known as | TLANDO | “The primary objective was the efficacy of oral testosterone undecanoate (TLANDO; Antares Pharma Inc.) in male patients with documented hypogonadism.” PMID 39252657 ↗ Sep 20241“Subjects received 225 mg of oral testosterone undecanoate (TLANDO) twice a day for 24 days without dose adjustment.” PMID 34994093 ↗ Jan 2022 |
| Action | Inhibit | “exogenous testosterone can suppress LH levels” NCT01206270 ↗ |
| Modality | Small molecule | “androgenic steroids” NCT00230984 ↗ |
| Route | Oral | “Oral testosterone undecanoate (40 mg daily for women, 80 mg twice daily for men) and an oral nutritional supplement (475 kcal/d) were administered” PMID 19144729 ↗ Jan 2009 |