estradiol valerate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | DELESTROGEN | — | 1954-07-15 | fda.gov ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05332106 | Mar 2022 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02272647 | Dec 2014 → Dec 2016 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00490308 | Aug 2007 → Aug 2008 | infertility disorder | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 24 trials · 1 missed | ||||||
| Phase 2 | NCT01310647 | Jun 2011 → Dec 2012 | ovarian disorder | La Fe Health Research Institute | Completed | Missed primary |
| Phase 2 | NCT00318799 | Apr 2006 → May 2007 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00185224 | Mar 2005 → Mar 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00805415 | Mar 2003 → Feb 2004 | anovulation | Bayer | Completed | No outcome recorded |
| Phase 311 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT02251925 | Sep 2012 → Oct 2015 | infertility disorder | Royan Institute | Unknown | No outcome recorded |
| Phase 3 | NCT01638923 | Jun 2012 → Jun 2015 | hemometra | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01638910 | Jun 2012 → Nov 2014 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00909857 | Apr 2009 → Nov 2010 | primary dysmenorrhea | Bayer | Completed | Missed primary |
| Phase 3 | NCT00764881 | Jan 2009 → Jul 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00778609 | Dec 2008 → Dec 2010 | headache disorder, pelvis syndrome | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00754065 | Sep 2008 → May 2011 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT00307801 | Feb 2006 → May 2008 | hemometra | Bayer | Completed | Met primary |
| Phase 3 | NCT00293059 | Dec 2005 → May 2008 | hemometra | Bayer | Completed | Met primary |
| Phase 3 | NCT00206583 | Mar 2005 → Jun 2007 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00185367 | Mar 2005 → Sep 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 414 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT06181305 | Feb → Nov 2024 | — | Rahem Fertility Center | Unknown | No outcome recorded |
| Phase 4 | NCT05753098 | Jan 2021 → Jan 2023 | female infertility | Beni-Suef University | Completed | No outcome recorded |
| Phase 4 | NCT04507022 | Aug 2020 → Feb 2021 | female infertility, male infertility | Rahem Fertility Center | Completed | No outcome recorded |
| Phase 4 | NCT03976544 | May 2019 → Jan 2025 | pregnancy disorder with abortive outcome | CRG UZ Brussel | Terminated | Met primary |
| Phase 4 | NCT03789123 | Jan → Jul 2019 | — | Bagcilar Training and Research Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03620929 | Aug 2018 | Asherman syndrome | Fu Xing Hospital, Capital Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03757117 | Oct 2016 → Mar 2018 | HIV infectious disease | Asociación Civil Impacta Salud y Educación, Peru | Completed | No outcome recorded |
| Phase 4 | NCT02352090 | Apr 2015 → Dec 2018 | — | Helsinki University Central Hospital | Completed | Missed primary |
| Phase 4 | NCT01500863 | Nov 2011 → May 2012 | ovarian hyperstimulation syndrome | IVI Madrid | Completed | No outcome recorded |
| Phase 4 | NCT01419353 | Aug 2011 → Jun 2013 | infertility disorder | Meir Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01218386 | May 2010 → Jan 2012 | infertility disorder | University Hospital Brussels | Completed | No outcome recorded |
| Phase 4 | NCT00755963 | May 2009 → Jul 2011 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00335218 | Jul 2002 → Aug 2004 | premature menopause | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00860964 | Feb 1998 → Feb 2003 | osteoporosis | Peking Union Medical College | Completed | No outcome recorded |
| Phase not applicable13 trials · 1 missed | ||||||
| — | NCT07379502 | Mar → Jun 2026 | polycystic ovary syndrome | CMH Kharian Medical College | Completed | No outcome recorded |
| — | NCT07361263 | Jan 2026 → Feb 2027 expected | diabetes insipidus | University Hospital, Basel, Switzerland | Recruiting | No outcome recorded |
| — | NCT07003373 | Jul 2025 → Jul 2026 overdue | — | Malihe Mahmoudinia | Not yet recruiting | No outcome recorded |
| — | NCT07419594 | Aug 2024 → Dec 2027 expected | post-traumatic stress disorder | Charite University, Berlin, Germany | Recruiting | No outcome recorded |
| — | NCT06396208 | May → Oct 2024 | anovulation | Chulalongkorn University | Completed | No outcome recorded |
| — | NCT07422506 | Jan 2024 → Jan 2030 expected | pregnancy disorder with abortive outcome | The Third Xiangya Hospital of Central South University | Recruiting | No outcome recorded |
| — | NCT04590417 | Jan 2022 → Jan 2024 overdue | — | Thai Red Cross AIDS Research Centre | Active not recruiting | No outcome recorded |
| — | NCT03351205 | Nov 2017 → Nov 2018 | adhesions of uterus | Beijing Obstetrics and Gynecology Hospital | Unknown | No outcome recorded |
| — | NCT03346317 | Nov 2017 → May 2018 | adhesions of uterus | Beijing Obstetrics and Gynecology Hospital | Unknown | No outcome recorded |
| — | NCT03300518 | Nov 2017 → Jun 2021 | infertility disorder | Reproductive & Genetic Hospital of CITIC-Xiangya | Completed | Missed primary |
| — | NCT03301233 | Nov 2017 → Jul 2018 | — | Ain Shams University | Completed | No outcome recorded |
| — | NCT02161614 | Feb 2014 → Dec 2015 | — | Federal University of Minas Gerais | Completed | No outcome recorded |
| — | NCT01120665 | Feb 2002 → Feb 2009 | — | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Comparator or background therapy36 trials | ||||||
| Phase 0 | NCT05300841 Comparator | May 2022 → Apr 2023 | polycystic ovary syndrome | Sohag University | Unknown | No outcome recorded |
| Phase 1 | NCT05980091 Background | Sep 2023 → Dec 2026 | female infertility | ART Fertility Clinics LLC | Suspended | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04283435 Background | Sep 2021 → Mar 2022 | — | Cairo University | Unknown | No outcome recorded |
| Phase 1/2 | NCT07115082 Background | Oct 2024 → Dec 2025 overdue | primary ovarian failure | Yan Hongli | Recruiting | No outcome recorded |
| Phase 2 | NCT07041814 Comparator | Feb 2026 → Apr 2029 expected | Turner syndrome | Universiti Kebangsaan Malaysia Medical Centre | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02845388 Comparator | Sep 2015 → May 2016 | infertility disorder | Omar Ahmed El Sayed Saad | Completed | No outcome recorded |
| Phase 2 | NCT01221831 Comparator | Sep 2010 → Sep 2011 | — | Estetra | Completed | No outcome recorded |
| Phase 2/3 | NCT01933204 Comparator | Sep 2013 → Aug 2015 | — | Chengdu University of Traditional Chinese Medicine | Completed | No outcome recorded |
| Phase 2/3 | NCT01300676 Comparator | Mar 2009 → Jan 2010 | — | Universiti Sains Malaysia | Completed | No outcome recorded |
| Phase 3 | NCT03832894 Comparator | Dec 2018 → Dec 2019 | infertility disorder | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT03788681 Comparator | Apr 2018 → Aug 2019 | — | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT00816556 Comparator | Oct 2008 → Sep 2011 | postmenopausal atrophic vaginitis | Maire Mac Bride | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT07499804 Comparator | Oct 2023 → Apr 2026 overdue | female infertility | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 4 | NCT07526207 Comparator | May 2022 → Mar 2026 | infertility disorder | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT04002635 Comparator | Dec 2020 → Apr 2021 | anovulation, female infertility, polycystic ovary syndrome | CRG UZ Brussel | Withdrawn | No outcome recorded |
| Phase 4 | NCT03642665 Comparator | Sep 2018 → Nov 2024 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT03060304 Comparator | Mar 2017 → Dec 2019 | endometrial disorder | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 4 | NCT02330757 Comparator | Oct 2016 → Dec 2024 | infertility disorder | Mansoura University | Unknown | No outcome recorded |
| Phase 4 | NCT03124524 Comparator | Jan 2015 → Sep 2016 | primary dysmenorrhea | Adana Numune Training and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02352597 Comparator | Jan 2013 → Jan 2015 | polycystic ovary syndrome | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT01822288 Comparator | Nov 2012 → Jul 2021 | — | Far Eastern Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01501448 Comparator | Jan → May 2012 | infertility disorder | IVI Madrid | Completed | No outcome recorded |
| Phase 4 | NCT01353846 Comparator | May 2011 → Nov 2012 | infertility disorder | Instituto Valenciano de Infertilidad, IVI VALENCIA | Unknown | No outcome recorded |
| Phase 4 | NCT01052623 Background | Jan 2010 → Dec 2011 | ataxia telangiectasia | Johann Wolfgang Goethe University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00843570 Comparator | Nov 2009 → May 2013 | infertility disorder | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT01698164 Comparator | Dec 2008 → Oct 2012 | breast cancer, cardiovascular disorder, osteoporosis, premature menopause | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| — | NCT07416578 Background | Jan → Dec 2026 expected | adhesions of uterus | Sixth Affiliated Hospital, Sun Yat-sen University | Active not recruiting | No outcome recorded |
| — | NCT07020429 Background | Sep 2025 → Jul 2030 expected | primary ovarian failure | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| — | NCT05112692 Comparator | Nov 2021 → Nov 2023 | polycystic ovary syndrome | Mansoura University | Unknown | No outcome recorded |
| — | NCT05189145 Background | Oct 2019 → Mar 2021 | female infertility | Alexandria University | Completed | No outcome recorded |
| — | NCT03854175 Comparator | Feb 2019 → Jan 2020 | infertility disorder | Cairo University | Unknown | No outcome recorded |
| — | NCT03329898 Background | Oct 2017 → Oct 2018 | adhesions of uterus | Beijing Obstetrics and Gynecology Hospital | Unknown | No outcome recorded |
| — | NCT03155048 Comparator | May → Oct 2017 | infertility disorder | Memorial Sisli Hospital, Istanbul | Completed | No outcome recorded |
| — | NCT02855632 Background | Aug 2016 → Dec 2018 | adhesions of uterus | Sir Run Run Shaw Hospital | Unknown | Missed primary |
| — | NCT02114645 Background | Apr 2014 → Feb 2015 | infertility disorder | Zekai Tahir Burak Women's Health Research and Education Hospital | Unknown | No outcome recorded |
| — | NCT02496052 Background | Jan 2013 → Jan 2017 | adhesions of uterus | Beijing Obstetrics and Gynecology Hospital | Unknown | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | Advanz Pharma | ADVANZ PHARMA Acquires Territory Rights to Progynova® and Cyclo-Progynova® in Selected Countries in EMEA and Global Rights to Ilomedin® advanzpharma.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 87 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | estradiol valerate | “A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin...” NCT00335218 ↗78“Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2...” NCT01638910 ↗ “Oral estradiol valerate 8 mg/day Oral estradiol valerate administered as 2 mg tablets for a total daily dose of 8 mg (four active tablets daily), starting on cycle day 2 for...” NCT07526207 ↗ “The Climen control group is prescribed a tablet containing estradiol valerate 2 mg/day for the first 11 days, and a tablet containing estradiol valerate 2 mg/day plus...” PMID 24886348 ↗ May 2014 “Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine estrogens \& MPA.” NCT01822288 ↗ “Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel.” PMID 21679006 ↗ 2011 “Participants will begin oral administration of Utrogestan (estradiol valerate) on the 5th day of menstruation at a dose of 1 mg daily for 21 consecutive days.” NCT07020429 ↗ “2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo.” NCT01638923 ↗ “1 day after medical abortion, give oral estradiol valerate, 1 mg Bid, for 21 days, and add dydrogesterone 10 mg Bid for the next 7 days.” NCT07422506 ↗ “Estradiol valerate is initiated at 4 mg/day on day 2 of the menstrual cycle and is adjusted to 8 mg/day based on endometrial thickness.” NCT07003373 ↗ “In the control group with oral route (n=160), at the time of cycle, 6 milligrams of oral estradiol valerate was started daily.” NCT03155048 ↗ |
| Known as | Climen | “3 mg of estradiol valerate (Climen) was taken twice a day” NCT07416578 ↗ |
| Known as | Cyclo-Progynova | “oral estradiol valerate (Cyclo-Progynova ® 2mg, white tablets, BAYER Schering Pharma)” NCT03301233 ↗1“oral estradiol " estradiol valerate " (Cyclo-Progynova)” NCT03788681 ↗ |
| Known as | E2 V | “OBJECTIVES: To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in...” PMID 23638631 ↗ May 20134“Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine estrogens \& MPA.” NCT01822288 ↗ “a COC containing a progestin with an anti-androgenic profile (estradiol valerate [E2 V]/dienogest [DNG]) to that of one with an androgenic progestin” PMID 24034466 ↗ Sep 2013 “comprising estradiol valerate/dienogest (E2V/DNG; administered using a dynamic dosing regimen)” PMID 19835717 ↗ May 2009 “estradiol valerate/dienogest (E(2)V/DNG)” PMID 21721593 ↗ 2011 |
| Known as | E2 valerate | “OBJECTIVE: To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with...” PMID 21422847 ↗ Apr 20111“Similarly, 50 patients received 4 mg/day oral E2 valerate from day 20 for 5-12 days, until the day before starting stimulation.” PMID 24074027 ↗ Sep 2013 |
| Known as | oestradiol valerate | “consisting of oestradiol valerate at a dose of 6 mg per day for 21-28 days with the addition of medroxyprogesterone acetate at a dose of 6 mg per day for the last 7-10 days of...” NCT02855632 ↗4“Exogenous oestradiol in the form of 2 mg oral oestradiol valerate , three times daily will be started on the 2nd or 3rd day of the cycle.” NCT06181305 ↗ “Oral FHT (oestradiol valerate 2 mg and cyproterone acetate 25 mg) was initiated at baseline and continued until week 9” PMID 40390323 ↗ May 2025 “Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle.” NCT03642665 ↗ |
| Known as | Progynova | “Progynova is an oral hormone replacement therapy containing the active ingredient estradiol valerate, a synthetic ester of 17β-estradiol that, upon ingestion, is rapidly...” NCT07041814 ↗2“Experimental group: estradiol valerate (Progynova, 2x2mg per day, 2mg in the morning, 2mg in the evening), orally, during 6-10 consecutive days from day 25 of the cycle onwards.” NCT01218386 ↗ “Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle.” NCT03642665 ↗ |
| Known as | Utrogestan | “Participants will begin oral administration of Utrogestan (estradiol valerate) on the 5th day of menstruation at a dose of 1 mg daily for 21 consecutive days.” NCT07020429 ↗ |
| Known as | Valerate estradiol | “Valerate estradiol 4mg/day during 10 days, starting the second day of the cycle prios to the ICSI cycle.” NCT01310647 ↗ |
| Action | Activate | “Estradiol valerate is an estradiol ester, or a prodrug of estradiol. As such, it is an estrogen, or an agonist of the estrogen receptors.” NCT05300841 ↗ |
| Route | Oral | “novel oral contraceptive” PMID 21721593 ↗ 2011 |