Drugs / Estradiol
Estradiol
also known as
17β-estradiol · Estrace · oestradiol · Vagifem · 17beta-estradiol · Climara · estradiol hemihydrate · Estring · +45 more
Other / unclassified targets ACE2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed postmenopausal atrophic vaginitis 1 milestone | |||||
| Filed | Other | Joyesta | postmenopausal atrophic vaginitis | 2019-10-30 | “Knight's New Drug Submission (NDS) for Joyesta™ has been accepted for review by Health Canada.” therapeuticsmd.com ↗ |
| Approved Indication not stated 10 milestones | |||||
| Filed | US (FDA) | BIJUVA | vasomotor symptoms due to menopause | 2021-05-25 | “submitted a New Drug Application prior-approval efficacy supplement for BIJUVA 0.5 mg/100 mg (estradiol and progesterone) capsules to the U.S. Food and Drug Administration” therapeuticsmd.com ↗ “submitted a supplemental New Drug Application (“sNDA”) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration (“FDA”).” therapeuticsmd.com ↗ |
| Label expansions (2) | US (FDA) | DIVIGEL | — | 2018-08-17 – 2019-12-12 | fda.gov ↗ |
| Label expansion | US (FDA) | MINIVELLE | — | 2014-09-23 | fda.gov ↗ |
| Approved | EU (EMA) | Zoely | — | 2011-07-26 | europa.eu ↗ |
| Label expansion | US (FDA) | VAGIFEM | — | 2009-11-25 | fda.gov ↗ |
| Label expansion | US (FDA) | ESTRADIOL | — | 2002-05-03 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | CLIMARA | — | 1997-04-11 – 2001-04-05 | fda.gov ↗ |
| Label expansion | US (FDA) | VIVELLE | — | 2000-02-25 | fda.gov ↗ |
| Label expansion | US (FDA) | ESTRADERM | — | 1991-10-24 | fda.gov ↗ |
| Approved | US (FDA) | ESTRACE | — | 1975-07-23 | fda.gov ↗ |
Trials 273 · started per year
today
US approved 1975
EU approved 2011
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 08 trials | ||||||
| Phase 0 | NCT06369363 | Sep 2026 → Sep 2028 expected | cardiovascular disorder | Milton S. Hershey Medical Center | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT05458375 | Dec 2022 → Apr 2023 | pelvic organ prolapse | University of South Florida | Terminated | No outcome recorded |
| Phase 0 | NCT03973229 | Nov 2019 → Apr 2025 | post-traumatic stress disorder | Emory University | Completed | No outcome recorded |
| Phase 0 | NCT04036500 | Sep 2019 → Jul 2020 | — | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 0 | NCT03401047 | Nov 2017 → Oct 2025 overdue | polycystic ovary syndrome | University of Virginia | Recruiting | No outcome recorded |
| Phase 0 | NCT03069781 | May 2017 → May 2018 | muscular atrophy | McMaster University | Withdrawn | No outcome recorded Stop: Business |
| Phase 0 | NCT02486757 | Apr 2015 → Mar 2016 | menstrual disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 0 | NCT02042196 | Dec 2013 → May 2016 | — | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 130 trials · 2 met primary · 1 missed | ||||||
| Phase 1 | NCT07794150 | Aug 2026 → May 2027 expected | — | Corium Innovations, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07851649 | Jul → Sep 2026 overdue | — | Corium Innovations, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06546397 | May 2024 → Sep 2025 overdue | pregnancy disorder | Women's Hospital School Of Medicine Zhejiang University | Recruiting | No outcome recorded |
| Phase 1 | NCT04283656 | Jan → Oct 2022 | HIV infectious disease | Thomas Jefferson University | Completed | Missed primary |
| Phase 1 | NCT05678192 | Dec 2021 → Mar 2023 | — | Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04760691 | Mar 2021 → Mar 2025 | HIV infectious disease | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT04714554 | Jan → Mar 2021 | — | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 1 | NCT05418426 | Aug 2020 → Apr 2021 | postmenopausal atrophic vaginitis | Daré Bioscience, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04021017 | Jan 2020 → Dec 2022 | anorexia nervosa | University of Saskatchewan | Withdrawn | No outcome recorded |
| Phase 1 | NCT03681691 | May 2019 → Jul 2021 | dementia, type 2 diabetes mellitus | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03556800 | May 2018 → Jun 2022 | — | Viramal Limited | Unknown | No outcome recorded |
| Phase 1 | NCT02792153 | Dec 2016 → Aug 2018 | anorexia nervosa | Johns Hopkins University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04330677 | Sep 2016 → Jan 2020 | — | University Hospital, Bonn | Completed | No outcome recorded |
| Phase 1 | NCT04978688 | Jun → Sep 2016 | — | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01862835 | May 2013 → Sep 2016 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT02673606 | Jan 2013 → Apr 2019 | specific phobia | NYU Langone Health | Completed | No outcome recorded |
| Phase 1 | NCT01265017 | Jul 2012 → Jun 2020 | type 1 diabetes mellitus | Sansum Diabetes Research Institute | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02349113 | Feb → Sep 2012 | osteoporosis | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT01293747 | Feb → Aug 2011 | — | Productos Científicos S. A. de C. V. | Completed | No outcome recorded |
| Phase 1 | NCT01085877 | Mar → May 2010 | postmenopausal atrophic vaginitis | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00870220 | Apr 2009 → Mar 2011 | Turner syndrome | University of Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00864214 | Jun 2008 → Dec 2009 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00779532 | May → Nov 2008 | — | Organon and Co | Completed | Met primary |
| Phase 1 | NCT01596010 | Oct → Nov 2007 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00711607 | May → Sep 2007 | — | Organon and Co | Completed | No outcome recorded |
| Phase 1 | NCT01157182 | Feb → Apr 2007 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT01486979 | Jan → May 2007 | postmenopausal atrophic vaginitis | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01477632 | Mar → Jun 2005 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00001259 | Aug 1992 → Feb 2020 | premenstrual tension | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 1 | NCT00044837 | — | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 1/25 trials · 1 missed | ||||||
| Phase 1/2 | NCT04685148 | Feb 2021 → Dec 2026 expected | major depressive disorder, postpartum depression | Vibe G Frøkjær, MD, PhD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05737329 | Mar 2019 → Apr 2023 | primary ovarian failure | Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare | Unknown | No outcome recorded |
| Phase 1/2 | NCT02726971 | Apr → Aug 2016 | Asherman syndrome | Fu Xing Hospital, Capital Medical University | Completed | Missed primary |
| Phase 1/2 | NCT01268046 | Nov 2009 → Dec 2013 | amnestic disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT00001322 | Jun 1994 → Mar 2020 | — | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 251 trials · 3 met primary · 3 missed | ||||||
| Phase 2 | NCT06318403 | Mar 2028 → Dec 2030 expected | rotator cuff syndrome | University of Utah | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07868536 | Sep 2026 → Mar 2028 expected | chronic pain syndrome, post-traumatic stress disorder | University of North Carolina, Chapel Hill | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07041814 | Feb 2026 → Apr 2029 expected | Turner syndrome | Universiti Kebangsaan Malaysia Medical Centre | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06686537 | Feb 2025 → Oct 2026 expected | female infertility, obesity disorder | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT06279195 | Jun 2024 → Nov 2025 | pelvis syndrome | Endeavor Health | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06191289 | Mar → Dec 2024 | — | University of Illinois at Chicago | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06005610 | Jan 2024 → Aug 2025 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT05982470 | Aug 2023 → Jun 2025 | cerebrovascular disorder, cognitive impairment with or without cerebellar ataxia | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05716516 | May 2023 → May 2027 expected | breast cancer | Dartmouth-Hitchcock Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05472779 | Jan 2023 → Jun 2025 | urinary tract infection | Stephanie Wang Zuo | Completed | No outcome recorded |
| Phase 2 | NCT05095597 | Apr 2022 → Jan 2025 | Asherman syndrome | IVI Foundation | Completed | No outcome recorded |
| Phase 2 | NCT03875378 | Aug 2020 → Aug 2028 expected | anorexia nervosa | Pouneh K. Fazeli, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05774405 | Jul 2020 → Jul 2021 | COVID-19 | Istanbul University - Cerrahpasa | Completed | No outcome recorded |
| Phase 2 | NCT04359329 | Apr → Jul 2020 | COVID-19 | Sharon Nachman | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06654570 | Apr 2020 → Oct 2024 | breast cancer | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04225221 | Feb 2020 → Apr 2022 | bulimia nervosa | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT04051320 | Jan 2020 → Jul 2022 | postpartum depression | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 2 | NCT03941730 | Aug 2019 → Jul 2024 overdue | female breast carcinoma, triple-negative breast carcinoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03740204 | Jun 2019 → Dec 2025 overdue | eating disorder, hypogonadism | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02670785 | Feb → Nov 2016 | postmenopausal atrophic vaginitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 2 | NCT02238808 | Aug 2015 → Jul 2018 overdue | estrogen-receptor positive breast cancer | AHS Cancer Control Alberta | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02349386 | Jul 2015 → Jun 2017 | prostate cancer | BHR Pharma, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02475265 | Jul 2015 → Jun 2018 | anorexia nervosa, osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01984138 | Sep 2013 → Jun 2025 overdue | estrogen-receptor positive breast cancer | Polly A. Niravath, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01923298 | Aug 2013 → Jun 2018 | breast cancer | University of Arizona | Completed | No outcome recorded |
| Phase 2 | NCT01928082 | Aug 2013 → Aug 2014 | idiopathic hypercalciuria, osteoporosis | University of Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01817530 | Apr 2013 → Jun 2015 | leiomyoma, uterine disorder | AbbVie | Completed | Met primary |
| Phase 2 | NCT01895881 | Apr 2013 → Dec 2018 | intracranial berry aneurysm | Rush University Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01670656 | Jan → Sep 2013 | dysmenorrhea | Organon and Co | Completed | Met primary |
| Phase 2 | NCT01709318 | Dec 2012 → Oct 2013 | — | Organon and Co | Completed | Missed primary |
| Phase 2 | NCT01586000 | Mar 2012 → May 2015 | anovulation | Kimberly Myer | Completed | No outcome recorded |
| Phase 2 | NCT01310647 | Jun 2011 → Dec 2012 | ovarian disorder | La Fe Health Research Institute | Completed | Missed primary |
| Phase 2 | NCT01126801 | May 2010 → Feb 2011 | — | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01083641 | Jan 2010 → Jun 2013 | breast cancer | University of Wisconsin, Madison | Terminated | No outcome recorded |
| Phase 2 | NCT00997893 | Dec 2009 → May 2015 | — | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 2 | NCT00866437 | Apr 2009 → May 2010 | premenstrual tension | EVE Medical Systems Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT00661531 | Apr 2008 → Jun 2015 | breast cancer | Georgetown University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00631124 | Feb → Oct 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00459810 | Feb 2007 → Jul 2009 | prostate cancer | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT00370019 | Aug 2006 → Dec 2011 | primary ovarian failure | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Withdrawn | No outcome recorded |
| Phase 2 | NCT00302731 | Feb 2006 → Jan 2014 | premature menopause | Jeanne Drisko, MD, CNS, FACN | Terminated | No outcome recorded |
| Phase 2 | NCT00176644 | May 2005 → Dec 2008 | prostate cancer | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded |
| Phase 2 | NCT00167648 | Mar 2005 → Dec 2006 | prostate cancer | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT01553773 | Jul 2004 → Mar 2005 | muscular atrophy | Federal University of São Paulo | Completed | Met primary |
| 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 | NCT02033512 | Jan 2003 → Jan 2004 | — | University Potiguar | Completed | No outcome recorded |
| Phase 2 | NCT00206557 | Oct 2002 → Apr 2007 | schizoaffective disorder, schizophrenia, schizophreniform disorder | The Alfred | 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 | NCT00206570 | Jan 2001 → Dec 2004 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Bayside Health | Completed | No outcome recorded |
| Phase 2 | NCT00005108 | Apr 2000 → Jan 2002 | atherosclerosis | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00001481 | Apr 1996 → Oct 2024 | postpartum depression | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 2/37 trials · 2 met primary | ||||||
| Phase 2/3 | NCT03479879 | Mar → Dec 2018 | pregnancy disorder with abortive outcome | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT02485821 | Jun 2015 → Feb 2016 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT01308814 | Oct 2010 → Mar 2016 | depressive disorder | University of North Carolina, Chapel Hill | Completed | Met primary |
| Phase 2/3 | NCT00775242 | Apr 2007 → Nov 2008 | — | Centro A.F. de Estudios Tecnologicos, S.A. | Completed | No outcome recorded |
| Phase 2/3 | NCT00268476 | Jul 2005 → Mar 2026 overdue | prostate cancer | Medical Research Council | Active not recruiting | Mixed |
| Phase 2/3 | NCT00088153 | Jul 2003 → Feb 2011 | anorexia nervosa | Massachusetts General Hospital | Completed | Met primary |
| Phase 2/3 | NCT00066157 | Sep 2001 → Dec 2007 | Alzheimer disease | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 364 trials · 12 met primary · 4 missed | ||||||
| Phase 3 | NCT07100782 | Dec 2025 → Aug 2028 expected | endometriosis, pelvis syndrome | University of Michigan | Recruiting | No outcome recorded |
| Phase 3 | NCT06969326 | May 2025 → Sep 2026 overdue | — | Women and Infants Hospital of Rhode Island | Recruiting | No outcome recorded |
| Phase 3 | NCT05862272 | Aug 2023 → Jul 2029 expected | endometriosis, leiomyoma | Sumitomo Pharma Switzerland GmbH | Recruiting | No outcome recorded |
| Phase 3 | NCT05620355 | Dec 2022 → May 2024 | leiomyoma | Bio Genuine (Shanghai) Biotech Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05617820 | Nov 2022 → Mar 2024 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 3 | NCT05264506 | Feb 2022 → Jan 2024 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04756037 | Mar 2021 → Feb 2025 | — | Sumitomo Pharma Switzerland GmbH | Completed | No outcome recorded |
| Phase 3 | NCT04192266 | Jun 2020 → May 2024 | post-traumatic stress disorder | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 3 | NCT03986944 | May 2019 → Jan 2021 | endometriosis | Kissei Pharmaceutical Co., Ltd. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03568708 | Nov 2018 → Jan 2023 | primary ovarian failure | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 3 | NCT03343067 | Dec 2017 → Oct 2018 | endometriosis | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03204331 | Nov 2017 → Apr 2020 | endometriosis | Myovant Sciences GmbH | Completed | Met primary |
| Phase 3 | NCT03271489 | Sep 2017 → Jun 2024 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03049735 | Apr 2017 → Apr 2019 | leiomyoma | Myovant Sciences GmbH | Completed | Met primary |
| Phase 3 | NCT03070899 | Apr 2017 → Apr 2020 | leiomyoma | ObsEva SA | Completed | Met primary |
| Phase 3 | NCT02884245 | Nov 2016 → Jul 2022 | infertility disorder | Centre Hospitalier Intercommunal Creteil | Completed | Met primary |
| Phase 3 | NCT03294538 | May 2016 → Feb 2017 | postmenopausal atrophic vaginitis | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02770365 | May → Nov 2016 | — | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT02922348 | Mar 2016 → Dec 2018 | primary ovarian failure | University of Pennsylvania | Withdrawn | No outcome recorded |
| Phase 3 | NCT02995694 | Mar → Dec 2016 | postmenopausal atrophic vaginitis | Alvogen Pine Brook LLC | Completed | No outcome recorded |
| Phase 3 | NCT02668783 | Feb → Sep 2016 | primary dysmenorrhea | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02668822 | Feb → Sep 2016 | primary dysmenorrhea | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02691494 | Feb 2016 → Feb 2018 | leiomyoma | AbbVie | Completed | Met primary |
| Phase 3 | NCT02668796 | Jan → Sep 2016 | postmenopausal atrophic vaginitis | Glenmark Pharmaceuticals Ltd. India | Completed | No outcome recorded |
| Phase 3 | NCT03848234 | Dec 2015 → Jul 2016 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Tangent Data | Completed | Met primary |
| Phase 3 | NCT02616146 | Dec 2015 → Oct 2016 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02224313 | Dec 2015 → Aug 2018 | — | Intira Sriprasert | Completed | No outcome recorded |
| Phase 3 | NCT02524288 | Aug 2015 → Sep 2016 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02253173 | Sep 2014 → Oct 2015 | postmenopausal atrophic vaginitis | TherapeuticsMD | Completed | Met primary |
| Phase 3 | NCT02195986 | Jun → Dec 2014 | postmenopausal atrophic vaginitis | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 3 | NCT01942668 | Aug 2013 → Oct 2016 | — | TherapeuticsMD | Completed | Mixed |
| Phase 3 | NCT01723579 | Jul 2013 → May 2015 | — | Organon and Co | Withdrawn | No outcome recorded |
| Phase 3 | NCT01845649 | Apr → Nov 2013 | postmenopausal atrophic vaginitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT01753102 | Nov 2012 → Apr 2013 | skin atrophy | Sun Pharmaceutical Industries, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01455597 | Oct 2011 → Dec 2012 | postmenopausal atrophic vaginitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT01501422 | Jul 2011 → Jan 2012 | — | Chulalongkorn University | Completed | Missed primary |
| Phase 3 | NCT01400776 | Jun 2011 → Feb 2012 | postmenopausal atrophic vaginitis | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00905723 | May 2009 → May 2010 | — | Federal University of São Paulo | Unknown | No outcome recorded |
| Phase 3 | NCT00687739 | May 2008 → Jun 2014 | obesity disorder | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 3 | NCT02847806 | Jan 2008 → Dec 2015 | hypogonadism, male | University Hospital, Caen | Completed | No outcome recorded |
| Phase 3 | NCT00522873 | Aug 2007 → Aug 2009 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT00446199 | Mar 2007 → Oct 2008 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT00431132 | Jan 2007 → Nov 2008 | postmenopausal atrophic vaginitis | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00426972 | Jan 2007 → Jul 2008 | ulcer of lower limbs | Renovo | Completed | No outcome recorded |
| Phase 3 | NCT00511433 | Oct 2006 → Jan 2008 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00511342 | Sep 2006 → Jun 2009 | — | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00413062 | Jun 2006 → Aug 2008 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00511199 | May 2006 → Apr 2008 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00303784 | Mar 2006 → Aug 2021 | anemia, osteoporosis, prostate cancer | University College, London | Unknown | Met primary |
| Phase 3 | NCT00185237 | Jul 2005 → Nov 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00127075 | Jun 2005 → Apr 2012 | multiple sclerosis | Hospices Civils de Lyon | Unknown | No outcome recorded |
| Phase 3 | NCT00160316 | Apr 2005 → Dec 2007 | — | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00108849 | Mar 2005 → May 2007 | postmenopausal atrophic vaginitis | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00727129 | Jul 2004 → Aug 2005 | — | Upsher-Smith Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00184795 | May 2004 → May 2005 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00310531 | Feb 2004 → Jun 2007 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00391417 | Sep 2003 → Apr 2005 | — | BioSante Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00560924 | Mar 2003 → Mar 2004 | urinary tract infection | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00043069 | Nov 2002 → Jun 2006 | osteoporosis, prostate cancer | Alliance for Clinical Trials in Oncology | Completed | Missed primary |
| Phase 3 | NCT00003771 | Sep 1997 → Feb 2004 | breast cancer | Regional Oncologic Center | Completed | Missed primary |
| Phase 3 | NCT00000559 | Mar 1995 → Aug 2001 | coronary artery disorder, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00464971 | Jan 1995 → Nov 1996 | postmenopausal atrophic vaginitis | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00465192 | Aug 1994 → Nov 1995 | postmenopausal atrophic vaginitis | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00026039 | Dec 1993 → ? | stroke disorder | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 469 trials · 5 met primary · 1 missed | ||||||
| Phase 4 | NCT07818278 | Oct 2026 → Aug 2029 expected | infertility disorder | University Hospital, Ghent | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07420218 | Sep 2026 → Jun 2030 expected | — | University of Delaware | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07831499 | Jul 2026 → Jul 2028 expected | — | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT07526948 | Jun 2026 → Jun 2031 expected | HIV infectious disease, postmenopausal atrophic vaginitis | Albert Einstein College of Medicine | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07278323 | Jan → Dec 2026 expected | frozen shoulder | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT06497894 | Jan → Jul 2026 overdue | insomnia | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 4 | NCT07580950 | Oct 2025 → Jun 2028 expected | functional hypothalamic amenorrhea | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06306404 | Oct 2025 → Oct 2029 expected | insomnia | VU University of Amsterdam | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06780163 | Jun → Nov 2025 | overactive bladder | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT07160504 | Mar → Dec 2025 overdue | postmenopausal atrophic vaginitis | University of Aarhus | Recruiting | No outcome recorded |
| Phase 4 | NCT06798571 | Mar 2025 → Dec 2026 expected | — | Penn State University | Recruiting | No outcome recorded |
| Phase 4 | NCT05457972 | Feb 2025 → Sep 2026 overdue | sexual disorder | University Hospitals Cleveland Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06808347 | Feb → Jun 2025 overdue | postmenopausal atrophic vaginitis | Walter Reed National Military Medical Center | Not yet 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 | NCT06353269 | Jun 2024 → Jun 2027 expected | hypogonadism, urinary tract infection | University of California, Irvine | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06264882 | Jun 2024 → May 2028 expected | — | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT05903820 | Jul 2023 → Oct 2024 | osteoporosis | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| Phase 4 | NCT05704036 | May 2023 → Jan 2027 expected | cystic fibrosis, hypogonadism | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 4 | NCT06324851 | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT06316219 | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT05538689 | Nov 2022 → Oct 2024 | leiomyoma, menstrual disorder | University of Chicago | Withdrawn | No outcome recorded |
| Phase 4 | NCT05221021 | Oct 2022 → Dec 2026 expected | overactive bladder | Walter Reed National Military Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05388656 | Jun 2022 → Dec 2024 | mood disorder | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 4 | NCT05282277 | Apr 2022 → Dec 2026 expected | atypical depressive disorder, depressive disorder, psychotic disorder | University of North Carolina, Chapel Hill | Recruiting | No outcome recorded |
| Phase 4 | NCT05551949 | Jan 2022 → Jun 2025 | cystitis, urinary tract infection | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT05156814 | Nov 2021 → Sep 2022 | — | Scientific Research Institute of Public Health, Russian Federation | Unknown | No outcome recorded |
| Phase 4 | NCT05021094 | Oct 2021 → Dec 2023 | primary ovarian failure | Affiliated Hospital of Nantong University | Unknown | No outcome recorded |
| Phase 4 | NCT04255160 | Oct 2020 → Sep 2026 overdue | — | University of Delaware | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04112368 | Sep 2020 → Aug 2024 | — | University of Illinois at Chicago | Completed | Met primary |
| Phase 4 | NCT04079218 | Sep 2020 → Aug 2023 | HIV infectious disease, postmenopausal atrophic vaginitis, premature aging syndrome | Kerry Murphy | Completed | No outcome recorded |
| Phase 4 | NCT04190927 | Jun 2020 → Jun 2023 | menstrual disorder | Women's Hormone Network | Unknown | No outcome recorded |
| Phase 4 | NCT05197374 | Jun 2020 → Feb 2021 | female infertility | Alexandria University | Completed | No outcome recorded |
| Phase 4 | NCT04050592 | Feb 2020 → Dec 2022 | atherosclerosis | Hanna Savolainen-Peltonen | Unknown | No outcome recorded |
| Phase 4 | NCT04043520 | Sep 2019 → Aug 2024 | abdominal obesity-metabolic syndrome | University of Colorado, Denver | Unknown | No outcome recorded |
| Phase 4 | NCT03724955 | Apr 2019 → Jun 2021 | cystic fibrosis | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03493126 | Oct 2018 → Sep 2020 | postmenopausal atrophic vaginitis | Ohio State University | Completed | No outcome recorded |
| Phase 4 | NCT04671966 | Sep 2018 → Dec 2024 | heart disorder | The University of Texas at Arlington | Unknown | No outcome recorded |
| Phase 4 | NCT03498313 | Jul 2018 → May 2021 | — | University of Illinois at Chicago | Completed | Mixed |
| Phase 4 | NCT02715232 | Feb 2017 → Dec 2020 | body integrity dysphoria | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 4 | NCT03779633 | Feb 2017 → Aug 2020 | pelvic organ prolapse | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT03077555 | Jan 2017 → Feb 2018 | anovulation | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT03720847 | Dec 2016 → Nov 2017 | — | University of North Carolina, Chapel Hill | Completed | Met primary |
| Phase 4 | NCT03033160 | Dec 2016 → Oct 2019 | — | Boston Urogynecology Associates | Unknown | No outcome recorded |
| Phase 4 | NCT02860897 | Jul 2016 → Apr 2017 | — | University Hospitals Cleveland Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT02255175 | Oct 2015 → Oct 2018 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT02264743 | Nov 2013 → Nov 2014 | venous thromboembolism | Royal Brompton & Harefield NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 4 | NCT01958073 | Oct 2013 → Dec 2017 | urinary tract infection | University of California, San Diego | Completed | Met primary |
| Phase 4 | NCT01715025 | Apr 2013 → Apr 2015 | menstrual disorder | Sydney Centre for Reproductive Health Research | Unknown | No outcome recorded |
| Phase 4 | NCT01295892 | Dec 2011 → Mar 2013 | — | Rio de Janeiro State University | Completed | No outcome recorded |
| Phase 4 | NCT01251263 | Oct 2010 → Oct 2012 | menstrual disorder, migraine disorder | Scott and White Hospital & Clinic | Unknown | No outcome recorded |
| Phase 4 | NCT01430650 | Jul 2010 → Oct 2014 | infertility disorder | Parc de Salut Mar | Completed | No outcome recorded |
| Phase 4 | NCT01065220 | Feb 2010 → Jan 2014 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00826839 | Jan 2009 → Sep 2010 | infertility disorder | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02618148 | Jan 2009 → Jun 2015 | — | Trieu, Nguyen Thi, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00785317 | Nov 2008 → Oct 2009 | — | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 4 | NCT00744328 | Aug 2008 → Sep 2013 | postpartum depression | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00701337 | Sep 2006 → Jan 2010 | — | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00185328 | Sep 2005 → Dec 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00160173 | Dec 2004 → Sep 2005 | — | ASCEND Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT00108238 | Apr 2003 → Dec 2006 | — | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00294463 | Feb 2003 → Mar 2005 | osteoporosis | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00431093 | Nov 2002 → Mar 2005 | — | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00732693 | Feb 2002 → Nov 2006 | primary ovarian failure | University of Edinburgh | Completed | Mixed |
| Phase 4 | NCT00224094 | Jan 2002 → May 2003 | — | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01705249 | Aug 2001 → Jun 2003 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT03921736 | Jan 2000 → Mar 2001 | essential hypertension | Anna Posadzy-Małaczyńska | Completed | No outcome recorded |
| Phase 4 | NCT00361075 | Jul 1998 → May 2005 | cardiovascular disorder | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT00252408 | Oct 1990 → Dec 2003 | osteoporosis | University of Aarhus | Completed | Met primary |
| Phase not applicable39 trials · 3 missed | ||||||
| — | NCT07620587 | Jun 2026 → Aug 2028 expected | — | Wilfrid Laurier University | Recruiting | No outcome recorded |
| — | 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 |
| — | NCT07617454 | Feb 2026 → Aug 2027 expected | — | Mette Hansen | Recruiting | No outcome recorded |
| — | NCT07173127 | Sep 2025 → Dec 2026 expected | uterine benign neoplasm | University Hospital, Geneva | Recruiting | No outcome recorded |
| — | NCT06715514 | Feb 2025 → Dec 2026 expected | type 2 diabetes mellitus | Lia Bally | Recruiting | No outcome recorded |
| — | NCT06136208 | Dec 2023 → Oct 2024 | — | Science Valley Research Institute | Completed | No outcome recorded |
| — | NCT06358014 | May 2023 → Dec 2024 | depressive disorder | Xiao Wang | Unknown | No outcome recorded |
| — | NCT07145281 | Nov 2022 → Nov 2024 | coagulation protein disease, vascular hemostatic disease | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| — | NCT07398924 | Jan 2022 → Jun 2023 | anovulation, female infertility | Yuzuncu Yil University | Completed | No outcome recorded |
| — | NCT06312033 | Aug 2018 → Jul 2019 | — | International Research Training Group 2804 | Completed | No outcome recorded |
| — | NCT03578172 | Jul 2018 → Oct 2019 | adhesions of uterus, female infertility | Reproductive & Genetic Hospital of CITIC-Xiangya | Completed | No outcome recorded |
| — | NCT03043924 | Sep 2017 → Apr 2022 | polycystic ovary syndrome | University Hospital, Lille | Completed | No outcome recorded |
| — | NCT03651427 | Feb 2017 → Mar 2019 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT02984696 | Mar 2015 → Oct 2016 | functional hypothalamic amenorrhea | Catholic University of the Sacred Heart | Unknown | No outcome recorded |
| — | NCT01762943 | Aug 2013 → Oct 2016 | postpartum depression | University of North Carolina, Chapel Hill | Completed | Missed primary |
| — | NCT01790282 | Mar 2013 → Dec 2014 | infertility disorder | Mansoura Integrated Fertility Center | Completed | No outcome recorded |
| — | NCT01659008 | Jun 2012 → Dec 2015 | menstrual disorder | Kay I Waud MD PhD | Unknown | No outcome recorded |
| — | NCT01546454 | Feb → Jun 2012 | coronary artery disorder | Oregon Health and Science University | Completed | No outcome recorded |
| — | NCT01780610 | Jan 2012 → Jan 2015 | infertility disorder | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| — | NCT01633814 | Sep 2011 → Aug 2015 | — | University of Missouri-Columbia | Terminated | No outcome recorded |
| — | NCT01381016 | Jun 2011 → Jan 2013 | infertility disorder, obesity disorder | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT01428245 | Apr 2011 → May 2013 | polycystic ovary syndrome | University of Virginia | Terminated | No outcome recorded |
| — | NCT01385280 | Feb 2011 → Jan 2013 | estrogen-receptor positive breast cancer, female breast carcinoma, progesterone-receptor positive breast cancer | University of Arizona | Completed | No outcome recorded |
| — | NCT01780558 | Jan 2010 → Jan 2015 | infertility disorder | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| — | NCT00984399 | Sep 2009 → May 2024 | female breast carcinoma, postmenopausal atrophic vaginitis | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| — | NCT00789802 | Nov 2008 → Jan 2010 | hemorrhagic disease | Washington University School of Medicine | Completed | Mixed |
| — | NCT00563576 | Sep 2007 → Feb 2009 | hemometra | Columbia University | 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 |
| — | NCT00608062 | Mar 2007 → Oct 2012 | arteriosclerosis disorder | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT01428193 | Sep 2006 → Aug 2017 | polycystic ovary syndrome | University of Virginia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00307775 | Mar 2006 → Oct 2011 | — | London North West Healthcare NHS Trust | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00435175 | Jun 2005 → Jul 2006 | — | University of Aarhus | Completed | No outcome recorded |
| — | NCT01087593 | Aug 2001 → Oct 2007 | fibromyalgia | Ostergotland County Council, Sweden | Terminated | Missed primary |
| — | NCT00006133 | Jun 2000 → ? | systemic lupus erythematosus | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| — | NCT01425541 | Apr 2000 → Aug 2025 | polycystic ovary syndrome | University of Virginia | Unknown | No outcome recorded |
| — | NCT00825617 | Oct 1996 → Oct 1999 | Turner syndrome | University of Aarhus | Completed | No outcome recorded |
| — | NCT00877097 | Jul 1996 → Dec 2002 | osteoporosis | Kuopio University Hospital | Completed | No outcome recorded |
| — | NCT00029757 | — | — | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Comparator or background therapy118 trials | ||||||
| Phase 0 | NCT05645393 Comparator | Jun 2024 → Mar 2025 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 0 | NCT05645406 Comparator | May 2024 → Jun 2025 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 0 | NCT04597099 Background | Oct 2022 → Oct 2025 | polycystic ovary syndrome | University of Virginia | Unknown | No outcome recorded |
| Phase 0 | NCT05387577 Comparator | Dec 2021 → Nov 2022 | blood coagulation disease | Medical College of Wisconsin | Terminated | No outcome recorded |
| Phase 1 | NCT03837015 Comparator | Nov 2019 → Dec 2021 | HIV infectious disease, bacterial vaginosis | McMaster University | Completed | No outcome recorded |
| Show all 118 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 65
| Date | Issuer | Release |
|---|---|---|
| 2026-06-23 | AbbVie | Regulatory AbbVie Announces European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus Infection abbvie.com ↗
MAVIRET ® (glecaprevir/pibrentasvir) is now approved in the European Union for the treatment of acute hepatitis C virus (HCV) infection with compensated liver disease (with or without cirrhosis) in adults and children aged 3 years and older. |
| 2026-05-22 | AbbVie | Regulatory AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection abbvie.com ↗ |
| 2025-12-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Provides Pipeline Update on Four Regulatory Milestones viatris.com ↗
The U.S. FDA has accepted for review the New Drug Application (NDA) for the Company's investigational low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception. |
| 2023-04-18 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Estradiol Transdermal System zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP, 0.014 m g/day (weekly) (USRLD: Menostar ® Transdermal System). |
| 2022-12-02 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Estradiol Transdermal System which will be manufactured at the Moraiya plant zyduslife.com ↗
Zydus receives final approval from the USFDA for Estradiol Transdermal System which will be manufactured at the Moraiya plant |
| 2022-10-11 | Xiromed LLC | Regulatory Xiromed LLC Launches Estradiol Transdermal Gel 0.1% with a Competitive Generic Therapy (CGT) Designation xiromed.com ↗
Xiromed received final approval for its Abbreviated New Drug Application (ANDA) from the United States FDA with Competitive Generic Therapy (CGT) designation and is eligible for 180 days of CGT market exclusivity as the first generic approval to Divigel®. |
| 2022-08-05 | Pfizer | Regulatory Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis pfizer.com ↗
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. |
| 2022-06-17 | Pfizer | Results Myovant Sciences and Pfizer Announce Publication in The Lancet of Phase 3 SPIRIT 1 and SPIRIT 2 Studies of Once-Daily Relugolix Combination Therapy in Women With Endometriosis-Associated Pain pfizer.com ↗
As previously reported, both studies achieved their co-primary endpoints by demonstrating clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain in women with endometriosis. |
| 2022-06-02 | Pfizer | Regulatory Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® pfizer.com ↗ |
| 2022-05-06 | Pfizer | Regulatory Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application (sNDA) for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis pfizer.com ↗ |
| 2022-04-12 | Pfizer | Regulatory Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated with Endometriosis pfizer.com ↗
The FDA noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review. |
| 2021-09-09 | Pfizer | Regulatory Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis pfizer.com ↗ |
| 2021-05-26 | Pfizer | Regulatory Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids pfizer.com ↗
The FDA approval of MYFEMBREE represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the U.S. |
| 2021-05-25 | TherapeuticsMD | Regulatory TherapeuticsMD Announces Submission of Low Dose BIJUVA® 0.5 mg/100 mg Supplemental New Drug Application to FDA therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, announced today that the Company submitted a supplemental New Drug Application (“sNDA”) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration (“FDA”). |
| 2021-04-08 | TherapeuticsMD | Regulatory TherapeuticsMD and Theramex Announce the Approval of BIJUVE® Capsules Indicated for Hormone Replacement Therapy in the United Kingdom and Under the Trade Name BIJUVA® in Belgium therapeuticsmd.com ↗
“The approval of BIJUVE in the UK and BIJUVA in Belgium marks a significant accomplishment by Theramex that offers a new treatment option to post-menopausal women,” |
| 2021-03-24 | Pfizer | Results Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids pfizer.com ↗
78.4% of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001) |
| 2021-02-17 | Pfizer | Results Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids pfizer.com ↗
In the LIBERTY studies, relugolix combination therapy improved the most bothersome symptoms of uterine fibroids and had a well-tolerated safety profile including maintenance of bone mineral density comparable to placebo. |
| 2021-01-26 | Pfizer | Results Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis pfizer.com ↗
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year |
| 2020-09-21 | TherapeuticsMD | Regulatory Knight and TherapeuticsMD Announce Health Canada Approval of BIJUVA® therapeuticsmd.com ↗
Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today the approval of BIJUVA® (estradiol and progesterone) capsules by Health Canada. |
| 2020-08-25 | Knight Therapeutics (USA) Inc | Regulatory Knight and TherapeuticsMD Announce Health Canada Approval of IMVEXXY® knighttx.com ↗
MONTREAL and BOCA RATON, Fla, Aug. 25, 2020 — Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today the approval of IMVEXXY ® by Health Canada. |
| 2020-08-25 | TherapeuticsMD | Regulatory Knight and TherapeuticsMD Announce Health Canada Approval of IMVEXXY® therapeuticsmd.com ↗
Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today the approval of IMVEXXY® by Health Canada. |
| 2020-05-29 | AbbVie | Regulatory FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women abbvie.com ↗
announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months. |
| 2020-02-03 | TherapeuticsMD | Regulatory TherapeuticsMD Announces Submission of New Drug Application Prior Approval Efficacy Supplement to the U.S. Food and Drug Administration for Lower Dose of BIJUVA® therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, announced today that it submitted a New Drug Application prior-approval efficacy supplement for BIJUVA 0.5 mg/100 mg (estradiol and progesterone) capsules to the U.S. Food and Drug Administration (FDA) late January 2020. |
| 2019-11-26 | Knight Therapeutics (USA) Inc | Regulatory Knight and TherapeuticsMD Announce Filing of New Drug Submission for Bijuva® in Canada knighttx.com ↗
Knight's New Drug Submission (NDS) for Bijuva ® has been accepted for review by Health Canada. |
| 2019-11-26 | TherapeuticsMD | Regulatory Knight and TherapeuticsMD Announce Filing of New Drug Submission for BIJUVA® in Canada therapeuticsmd.com ↗
Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today that Knight's New Drug Submission (NDS) for BIJUVA® has been accepted for review by Health Canada. |
| 2019-10-30 | Knight Therapeutics (USA) Inc | Regulatory Knight and TherapeuticsMD Announce Filing of New Drug Submission for Joyesta™ in Canada knighttx.com ↗
MONTREAL and BOCA RATON, Fla., Oct. 30, 2019 — Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today that Knight's New Drug Submission (NDS) for Joyesta™ has been accepted for review by Health Canada. |
| 2019-10-30 | TherapeuticsMD | Regulatory Knight and TherapeuticsMD Announce Filing of New Drug Submission for Joyesta™ in Canada therapeuticsmd.com ↗
Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today that Knight's New Drug Submission (NDS) for Joyesta™ has been accepted for review by Health Canada. |
| 2019-09-24 | TherapeuticsMD | Results TherapeuticsMD Announces Multiple Presentations Related to IMVEXXY® and BIJUVA® at the 2019 Annual Meeting of the North American Menopause Society therapeuticsmd.com ↗
We are excited to report results from the REPLENISH Phase 3 trial for BIJUVA that show improvements in several sleep parameters, including sleep disturbances, in menopausal women with moderate to severe vasomotor symptoms taking BIJUVA as compared to placebo. |
| 2019-08-02 | AbbVie | Regulatory AbbVie's MAVIRET™ (glecaprevir/pibrentasvir) Approved by European Commission to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis abbvie.com ↗ |
| 2019-05-03 | TherapeuticsMD | Results TherapeuticsMD Announces Oral and Poster Presentations on BIJUVA™ and ANNOVERA™ at the American College of Obstetricians and Gynecologists 2019 Annual Meeting therapeuticsmd.com ↗
Data from the REPLENISH Phase 3 trial for BIJUVA showed significant improvement in the frequency and severity of vasomotor symptoms, regardless of the number and severity of hot flushes at baseline. |
| 2019-03-25 | TherapeuticsMD | Results TherapeuticsMD Announces Oral and Poster Presentations on BIJUVA™ and ANNOVERA™ at the Endocrine Society 2019 Annual Meeting therapeuticsmd.com ↗
Data from the REPLENISH Phase 3 trial for BIJUVA showed improvements in hot flushes, night sweats, sweating, and quality of sleep. |
| 2019-03-08 | TherapeuticsMD | Results TherapeuticsMD Announces Oral Presentations on BIJUVA and ANNOVERA, and Poster Presentations Related to Menopause Symptoms and Treatments at 2019 ISSWSH/ISSM Joint Meeting therapeuticsmd.com ↗ |
| 2018-10-29 | TherapeuticsMD | Regulatory TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA™ (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical* hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus. |
| 2018-09-17 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Estradiol Vaginal Inserts USP, 10 mcg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Estradiol Vaginal Inserts USP, 10 mcg, the generic version of VAGIFEM®1, 10 mcg, of Novo Nordisk Inc. |
| 2018-05-31 | TherapeuticsMD | Results TherapeuticsMD Announces Clinical Abstract at the 2018 ASCO Annual Meeting therapeuticsmd.com ↗
“In patients who used IMVEXXY, serum estradiol levels remained within postmenopausal range with improvements in VVA-associated moderate to severe dyspareunia,” said Dr. Shari B. Goldfarb of Memorial Sloan Kettering Cancer Center. |
| 2018-05-30 | TherapeuticsMD | Regulatory TherapeuticsMD Announces FDA Approval of TX-004HR: IMVEXXY™ (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, due to Menopause therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXY™ (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. |
| 2018-03-08 | TherapeuticsMD | Regulatory TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced the acceptance of the NDA for TX-001HR by the U.S. Food and Drug Administration (FDA). |
| 2018-02-21 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗
The study also met all ranked secondary endpoints (p<0.001) at month six. |
| 2018-01-24 | Perrigo Company | Regulatory Perrigo Announces Final FDA Approval Of A Generic Version Of Estrace® Cream perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for the generic version of Estrace ® Cream (estradiol vaginal cream, USP, 0.01 % ). |
| 2017-12-28 | TherapeuticsMD | Regulatory TherapeuticsMD Announces Submission of New Drug Application for TX-001HR therapeuticsmd.com ↗
announced today that it has submitted the New Drug Application (NDA) for TX-001HR |
| 2017-12-19 | TherapeuticsMD | Regulatory TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR therapeuticsmd.com ↗ |
| 2017-11-29 | TherapeuticsMD | Regulatory TherapeuticsMD Announces Resubmission of New Drug Application for TX-004HR therapeuticsmd.com ↗ |
| 2017-11-06 | TherapeuticsMD | Regulatory TherapeuticsMD Announces Plan to Resubmit the New Drug Application for TX-004HR therapeuticsmd.com ↗
At the meeting, the Division agreed to the resubmission of the NDA for TX-004HR without the need for an additional pre-approval study. |
| 2017-09-14 | TherapeuticsMD | Regulatory TherapeuticsMD Announces Submission of Additional Endometrial Safety Information to the New Drug Application for TX-004HR therapeuticsmd.com ↗ |
| 2017-08-16 | TherapeuticsMD | Results TherapeuticsMD Announces Publication of Manuscript on the Women’s Health Initiative Observational Study of Vaginal Estrogen Use in Postmenopausal Women therapeuticsmd.com ↗
The study demonstrated no significant difference in the risk of invasive breast cancer, stroke, colorectal cancer, endometrial cancer, and venous thromboembolism in vaginal estrogen users vs nonusers. |
| 2017-08-10 | TherapeuticsMD | Regulatory TherapeuticsMD Provides TX-004HR Regulatory Update therapeuticsmd.com ↗
The FDA requested approximately six weeks to perform a comprehensive review of these data and has requested a meeting with the Company to discuss the outcome of this review. |
| 2017-07-28 | AbbVie | Regulatory European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Commission has granted marketing authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). |
| 2017-07-17 | TherapeuticsMD | Regulatory TherapeuticsMD Provides TX-004HR Regulatory Update therapeuticsmd.com ↗
The Company has received the minutes of the meeting and, per the FDA’s request, has formally submitted the new information for consideration related to the NDA for TX-004HR. |
| 2017-05-08 | TherapeuticsMD | Regulatory TherapeuticsMD Receives Complete Response Letter from FDA for TX-004HR New Drug Application therapeuticsmd.com ↗ |
| 2017-04-10 | TherapeuticsMD | Regulatory TherapeuticsMD Provides TX-004HR Regulatory Update therapeuticsmd.com ↗ |
| 2017-04-03 | TherapeuticsMD | Results TherapeuticsMD Presents Positive Phase 3 Data in Two Presentations for TX-001HR at ENDO 2017 therapeuticsmd.com ↗
The positive results of the pivotal phase 3 Replenish Trial data were featured in an oral and a poster presentation. |
| 2017-01-11 | TherapeuticsMD | Results TherapeuticsMD Announces Publication of Two Manuscripts on the Rejoice Trial for TX-004HR in Leading Peer-Reviewed Medical Journal therapeuticsmd.com ↗
The manuscripts review the positive results of TX-004HR across all pre-specified primary and secondary endpoints in the Rejoice Trial, as well as data from a pharmacokinetic (PK) substudy demonstrating the low systemic absorption of TX-004HR. |
| 2016-12-05 | TherapeuticsMD | Results TherapeuticsMD Announces Positive Top-Line Results from Pivotal Phase 3 Replenish Trial in Postmenopausal Women with Moderate to Severe Vasomotor Symptoms (VMS) Treated with TX-001HR therapeuticsmd.com ↗
TX-001HR, the first bio-identical combination therapy of estradiol and progesterone evaluated in a randomized, controlled clinical trial met all co-primary efficacy and safety endpoints at multiple doses |
| 2016-09-19 | TherapeuticsMD | Regulatory TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy™ (TX-004HR) therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced the acceptance of the NDA for Yuvvexy, the conditionally-approved trade name for TX-004HR, by the U.S. Food and Drug Administration (FDA). |
| 2016-08-04 | TherapeuticsMD | Regulatory TherapeuticsMD Announces Second Quarter 2016 Financial Results therapeuticsmd.com ↗
Submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration for Yuvvexy, the conditionally approved trade name for TX-004HR, the company’s applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate- to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. |
| 2016-07-07 | TherapeuticsMD | Regulatory TherapeuticsMD Announces New Drug Application Submission for Yuvvexy™ (TX-004HR) therapeuticsmd.com ↗
TherapeuticsMD, Inc. (NYSE MKT:TXMD), an innovative women’s healthcare company, announced today that it has submitted its New Drug Application (NDA) for Yuvvexy with the U.S. Food and Drug Administration (FDA). |
| 2016-05-14 | TherapeuticsMD | Results TherapeuticsMD Presents Poster at ACOG 2016 with Additional Secondary Endpoint Data from Phase 3 Rejoice Trial therapeuticsmd.com ↗
After 12 weeks, total FSFI scores increased with all three doses of Yuvvexy (4 mcg, 10 mcg, and 25 mcg) and placebo, with a statistically significant difference at the 10 mcg and 25 mcg doses versus placebo. |
| 2016-04-02 | TherapeuticsMD | Results TherapeuticsMD Presents Detailed Results from Phase 3 Rejoice Trial in Postmenopausal Women with Vulvar and Vaginal Atrophy (VVA) at ENDO 2016 therapeuticsmd.com ↗
TX-004HR Showed Statistically Significant Improvements in Dyspareunia (Vaginal Pain During Sexual Intercourse) and Vaginal Dryness at All Doses (25 mcg, 10 mcg and 4 mcg) |
| 2015-12-07 | TherapeuticsMD | Results TherapeuticsMD Announces Positive Top-Line Results from its Phase 3 Rejoice Trial in Postmenopausal Women with Vulvar and Vaginal Atrophy (VVA) Treated with 25 mcg, 10 mcg or 4 mcg of TX-004HR therapeuticsmd.com ↗ |
| 2014-09-26 | Hisamitsu Pharmaceutical Co., Inc. | Regulatory Noven Pharmaceuticals,Inc.プレスリリ－ス:ノーベン社はMinivelle®（エストラジオール経皮システム）の新用量において米国食品医薬品局から新たな効能効果の承認を取得 hisamitsu.co.jp ↗
Noven Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. |
| 2014-09-24 | Noven Therapeutics | Regulatory Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle® (Estradiol Transdermal System) noven.com ↗
Noven Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. |
| 2011-08-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives European Marketing Authorization for ZOELYTM Oral Contraceptive tevapharm.com ↗
Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA) announced today that its new oral contraceptive, ZOELYTM (NOMAC/E2 -nomegestrol acetate 2.5 mg/17B-estradiol 1.5 mg), has received a Marketing Authorization in the European Union (EU) for the prevention of pregnancy. |
| 2011-03-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Positive Opinion for NOMAC/E2 from the European Committee for Medicinal Products tevapharm.com ↗
The CHMP issued its positive opinion following a review of data derived from clinical trials evaluating NOMAC-E2. |
| 2003-12-08 | Kissei Pharmaceutical Co., Ltd. | Regulatory 経皮吸収エストラジオール製剤 「エストラダーム®Ｍ」の製造承認の承継について kissei.co.jp ↗
キッセイ薬品工業株式会社（代表取締役社長 神澤陸雄）は、経皮吸収エストラジオール製剤「エストラダームＭ」の製造承認を１２月８日付けにて、日本チバガイギー株式会社（代表取締役社長 大橋勇郎）から承継しましたのでお知らせ致します。 |
| 2002-04-11 | Kissei Pharmaceutical Co., Ltd. | Regulatory 経皮吸収エストラジオール製剤 「エストラダーム®Ｍ」の「閉経後骨粗鬆症」効能・効果追加のお知らせ kissei.co.jp ↗
４月１１日（木）付けにて「閉経後骨粗鬆症」の効能・効果の追加が承認されましたのでお知らせ致します。 |
All press releases naming this drug 94 releases
Evidence & citations 58 cited values
Every value below carries the sentence it was read from. 414 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | estradiol | “OBJECTIVE: To assess the effect of once-daily relugolix combination therapy (relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) compared with...” PMID 35675604 ↗ May 2022337“In the present analysis, the subjects received daily in the right and left forearm a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and...” NCT02033512 ↗ “2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol...” NCT07032506 ↗ “Participants received a single dose of estradiol gel (Estramon 2 mg estradiol, Hexal AG, Holzkirchen, Germany), applied to their shoulder, 3 hours prior to the fear extinction...” NCT04330677 ↗ “Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with estradiol and is applied in a timed, consistent fashion to postmenopausal or...” NCT00029757 ↗ “STUDY QUESTION: Does luteal estradiol (E2) pretreatment give a similar number of retrieved oocytes compared to no-pretreatment in advanced-aged women stimulated with...” PMID 39008826 ↗ Sep 2024 “This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and...” NCT04756037 ↗ “Forty insomniac postmenopausal women with no severe vasomotor symptoms and/or recognized hot flushes during sleep were randomized into 2 months' treatment with a 50-μg...” PMID 25242569 ↗ Nov 2014 “Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1...” NCT06497894 ↗ “The purpose of this study is to test the ability of risedronate and estradiol, alone or in combination, to prevent bone loss associated with androgen deprivation therapy in men...” PMID 19468757 ↗ May 2009 “Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day...” NCT00511342 ↗ |
| Known as | 17 beta-oestradiol | “doses of 25 micrograms 17 beta-oestradiol (E2)” PMID 1791769 ↗ Dec 1991 |
| Known as | 17beta-estradiol | “Two-hundred eighteen healthy women with intact uteri enrolled in the Estrogen in the Prevention of Atherosclerosis Trial (EPAT) or the Women's Estrogen-Progestin Lipid-Lowering...” PMID 17329508 ↗ Mar 20077“A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms...” NCT00465192 ↗ “To investigate the pharmacokinetics of 10 microg and 25 microg 17beta-estradiol (E2) vaginal tablets in postmenopausal women with vaginal atrophy.” PMID 20423242 ↗ Jun 2010 “Participants were randomised to receive 2.5 mg tibolone or 1 mg 17beta estradiol plus 0.5 mg norethisterone acetate (E2/NETA) daily for 48 weeks.” PMID 17995496 ↗ Dec 2007 “Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial” NCT00464971 ↗ “Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet)” NCT00108849 ↗ “17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)” NCT05802303 ↗ “transdermal 17-beta estradiol (TE) (100 mcg/d)” PMID 33470755 ↗ Jan 2021 |
| Known as | 17β-estradiol | “The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on...” NCT02524288 ↗36“OBJECTIVES: To investigate the long-term endometrial safety and bleeding pattern of the 0.25 mg drospirenone/0.5 mg 17β-estradiol (DRSP/E2) dose combination compared with 0.5...” PMID 23531117 ↗ May 2013 “The softgel 17β-estradiol (E2) vaginal inserts (4 and 10 μg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated...” PMID 31688572 ↗ Nov 2019 “Women with TS were treated with oral hormone substitution consisting of 2 mg 17β-estradiol/day for days 1-12, 2 mg 17β-estradiol/day and 1 mg norethisterone acetate/day for...” NCT00825617 ↗ “To evaluate the effect of investigational vaginal rings containing nomegestrol acetate (NOMAC) plus 17β-estradiol (E2) or etonogestrel (ENG) plus E2 in women with moderate to...” PMID 30439359 ↗ Nov 2018 “Data were derived from a randomized controlled clinical trial investigating 2 different doses of estradiol treatment (2 mg 17β-estradiol per day and placebo or 2+2 mg...” PMID 30571546 ↗ Jan 2019 “Forty-two patients received non-oral, conventional HT (1.5 mg/day percutaneous 17β-estradiol gel or equivalent for nasal route) for 3 months followed by 200 mg/day micronized...” PMID 25017924 ↗ Oct 2014 “Nomegestrol acetate (NOMAC)/17β-estradiol (E2) is a monophasic oral contraceptive that contains a progesterone-derived progestogen (NOMAC), and E2, a bio-identical estrogen.” PMID 24777591 ↗ Jun 2014 “Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion.” NCT01295892 ↗ “200 mg/day oral micronized natural progesterone (e.g. Utrogestan® 100mg) + 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg) during a year” NCT01123538 ↗ “Mature girls with AN (bone age [BA] ≥15 years, n = 96) were randomized to 100 µg of 17β-estradiol (with cyclic progesterone) or placebo transdermally for 18 months.” PMID 21698665 ↗ Oct 2011 |
| Known as | 17β-estradiol hemihydrate | “Eligible patients were treated with Vagifem® (17β-estradiol hemihydrate) 10 μg vaginal tablets for 12 weeks.” NCT06654570 ↗ |
| Known as | Alora | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00224094 ↗ |
| Known as | BAY86-5435 | “Menostar (Estradiol, BAY86-5435)” NCT00310531 ↗ |
| Known as | Bio-E-Gel | “Bio-E-Gel (Topical Estradiol Gel)” NCT00391417 ↗ |
| Known as | Climara | “At the same time, the patients in this arm received Estradiol patch (Climara 7.8 mg patch/week, Bayer, Germany) for 14 days.” NCT05774405 ↗ |
| Known as | DERMESTRIL SEPTEM | “Oral NOMA (LUTENYL® 10 mg/day) combined with transdermal Estradiol (DERMESTRIL SEPTEM® 75 mcg, once a week),” NCT00127075 ↗ |
| Known as | Divigel | “Plus Estradiol (Divigel, Gel for Topical Application, 0.1%)” NCT05156814 ↗ |
| Known as | E(2) | “The doses of estradiol (E(2)) and progesterone (P) were chosen to mimic levels across the normal follicular phase and have been shown previously to induce negative followed by...” PMID 21558550 ↗ May 20112“nomegestrol acetate (NOMAC) plus 17β-estradiol (E(2)) were investigated after a” PMID 22898360 ↗ Aug 2012 “estradiol (E(2))-group” PMID 18077316 ↗ Dec 2007 |
| Known as | ESTOGEL | “17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)” NCT05802303 ↗ |
| Known as | Estrabet Tablet | “Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)” NCT05802303 ↗ |
| Known as | Estrace | “Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2...” NCT03943823 ↗13“The vaginal estradiol cream Estrace (chosen due to lower cost than other vaginal estrogen formulations) will then be provided to the patient.” NCT06808347 ↗ “1mg/day for 3-days and 3mg/day for 7-days of 17β-estradiol (Estrace, Acerus Pharmaceuticals Corporation, Mississauga, ON, Canada).” NCT03069781 ↗ “Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)” NCT02995694 ↗ |
| Known as | Estrace Cream | “Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.” NCT03332303 ↗ |
| Known as | Estraderm | “200 mg/day oral micronized natural progesterone (e.g. Utrogestan® 100mg) + 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg) during a year” NCT01123538 ↗ |
| Known as | Estradiol (vivelle-dot) | “Estradiol (vivelle-dot)” NCT02969590 ↗ |
| Known as | estradiol 17-beta | “women in the trial received either oral estrogen (estradiol 17-beta at the standard replacement dose of 1 mg daily) or a matching placebo” NCT00026039 ↗ |
| Known as | Estradiol acetate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01070979 ↗ |
| Known as | estradiol hemihydrate | “They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac” NCT00877097 ↗3“Most patients who received HT were prescribed continuous combined or sequential estradiol hemihydrate and norethisterone.” PMID 18364505 ↗ Mar 2008 “Estradiol Hemihydrate(Estrabet Tablet, abbott pharma)” NCT05802303 ↗ “Drug: Estradiol Hemihydrate Transdermal System” NCT04021017 ↗ |
| Known as | Estradiol patch | “Drug: Estradiol patch” NCT04833140 ↗ |
| Known as | Estradiol/Levonorgestrel Transdermal System | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07794150 ↗ |
| Known as | Estradiol/Norethindrone acetate (E2/NETA) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01441635 ↗ |
| Known as | Estradot | “Estradot®: 50 micrograms/24h, transdermal patch E2” NCT06715514 ↗ |
| Known as | Estramon | “Participants received a single dose of estradiol gel (Estramon 2 mg estradiol, Hexal AG, Holzkirchen, Germany), applied to their shoulder, 3 hours prior to the fear extinction...” NCT04330677 ↗ |
| Known as | Estring | “ESTRING (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol.” NCT01984138 ↗ |
| Known as | Estrofem | “vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase” NCT01504139 ↗2“Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month” NCT00919919 ↗ “1 mg encapsulated estradiol (Estrofem®)” NCT05586724 ↗ |
| Known as | EstroGel | “EstroGel® 0.06% (1.25 g of gel)” NCT05645393 ↗ |
| Known as | EVC | “Estradiol Vaginal Capsule (EVC)” NCT02670785 ↗ |
| Known as | Femring | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00563576 ↗ |
| Known as | Imvexxy | “The softgel 17β-estradiol (E2) vaginal inserts (4 and 10 μg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated...” PMID 31688572 ↗ Nov 2019 |
| Known as | Menostar | “Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)” NCT00185237 ↗1“Menostar (Estradiol, BAY86-5435)” NCT00310531 ↗ |
| Known as | mylan | “Estradiol (mylan or vivelle dot patch)” NCT04255160 ↗ |
| Known as | Mylan Estradiol Transdermal System | “Mylan Estradiol Transdermal System 0.025 mg/day” NCT00649896 ↗ |
| Known as | oestraclin | “Patients will receive estrogenic therapy, based on estradiol, for 10±2 days (oestraclin, topical cream, 5µg daily for 10±2 days).” NCT05095597 ↗ |
| Known as | oestradiol | “Women with measured menstrual bleeding \>80ml per cycle and no contraindications to combined oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral...” NCT01715025 ↗10“Ryeqo® consists of an oral treatment, available as a pill, which contains 40 mg of the GnRH antagonist Relugolix, combined with 1 mg of oestradiol and a progestin, such as...” NCT07173127 ↗ “First line HRT was oral sequential oestradiol/norethisterone in women with intact uterus and oral continuous oestradiol in hysterectomised women.” NCT00252408 ↗ “Group A administered Femoston Conti - oral oestradiol 17β 0.5 mg/dydrogesterone 2.5 mg daily for the duration of the treatment phase (24 weeks)” NCT02264743 ↗ “260 postmenopausal women will be randomised to 100 mg mP or 0.5 mg NETA per day in continuous combination with 1 mg oestradiol” PMID 39448218 ↗ Oct 2024 “1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP” NCT00785317 ↗ “1 mg oestradiol and 0·5 mg norethisterone acetate” PMID 36116480 ↗ Sep 2022 |
| Known as | Oestrogel | “Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1...” NCT06497894 ↗1“Oestrogel® is a transdermal hormone replacement therapy containing 17β-estradiol in a hydroalcoholic gel formulation designed for topical application.” NCT07041814 ↗ |
| Known as | Provames | “Treatment with estradiol (Provames®, 3 mg morning and evening, or 6 mg per day) will start on the 1st or 2nd day of her period.” NCT05232344 ↗ |
| Known as | SHP00577E | “Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)” NCT00185237 ↗1“Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)” NCT00310531 ↗ |
| Known as | Systen | “In this study MHT consists of estradiol transdermal patches (50 mcg (Systen), which provide a stable release of estradiol and lead to more stable blood levels.” NCT06306404 ↗ |
| Known as | tE2 | “While transdermal E2 (TE2) reduces perimenopausal depressive symptoms” PMID 35809362 ↗ Jul 20222“50 µg/d transdermal 17β-estradiol (t-E2)” PMID 28846767 ↗ Oct 2017 “50 μg/d transdermal 17β estradiol (tE2)” PMID 32520900 ↗ Aug 2020 |
| Known as | Transdermal estradiol gel | “Drug: Transdermal estradiol gel” NCT06856174 ↗ |
| Known as | TX-004HR | “The 12-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 REJOICE trial demonstrated that TX-004HR, an investigational, applicator-free, low-dose vaginal...” PMID 28355090 ↗ Mar 2017 |
| Known as | Vagifem | “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms...” NCT00465192 ↗10“This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having...” NCT00431132 ↗ “One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg).” NCT02516202 ↗ “Vagifem (estradiol vaginal tablet) is a small, white round, film-coated, bi-convex vaginal insert, which measures 6 mm.” NCT01984138 ↗ “Eligible patients were treated with Vagifem® (17β-estradiol hemihydrate) 10 μg vaginal tablets for 12 weeks.” NCT06654570 ↗ “Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg” NCT02668796 ↗ “Estradiol 10 MCG Vaginal Tablet [VAGIFEM]” NCT04232813 ↗ “Vagifem® (estradiol), vaginal tablets” NCT05586711 ↗ |
| Known as | Vagifem (estradiol vaginal tablet) | “Vagifem (estradiol vaginal tablet)” NCT04079218 ↗ |
| Known as | Vagifem Low Dose | “Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet)” NCT00108849 ↗ |
| Known as | Vivelle | “transdermal estradiol patch (Vivelle)” NCT00361075 ↗ |
| Known as | Vivelle Dot | “treatment with 17β-estradiol (Vivelle Dot® 0.10 - 0.15 mg/day) or a look-alike placebo patch” NCT01208324 ↗ |
| Known as | vivelle dot patch | “Estradiol (mylan or vivelle dot patch)” NCT04255160 ↗ |
| Known as | Vivelle-Dot generic | “Estradiol in the form of a transdermal patch 100 mcg daily (Vivelle-Dot generic).” NCT04833140 ↗ |
| Known as | VML-0203 | “a Transdermal Estradiol Cream (VML-0203)” NCT03556800 ↗ |
| Known as | WC3011 | “WC3011 Estradiol Vaginal Cream” NCT01400776 ↗1“WC3011 Estradiol Vaginal Cream” NCT01455597 ↗ |
| Known as | Zesteem | “estradiol (Zesteem)” NCT00426972 ↗ |
| Action | Inhibit | “With tE2, testosterone is suppressed” PMID 41880608 ↗ Mar 2026 |
| Modality | Other / unclassified | “Transdermal Estradiol” NCT00001322 ↗ |
| Route | Oral | “receiving unopposed oral estradiol” PMID 17329508 ↗ Mar 2007 |
| Target | ACE2 | “17β estradiol reduces expression of ACE2” NCT04853069 ↗ |