conjugated estrogens
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | PREMARIN | — | 1998-09-08 – 2008-11-07 | fda.gov ↗ |
| Approved | US (FDA) | PREMARIN | — | 1942-05-08 | fda.gov ↗ |
Trials 64 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06520982 | Sep 2024 → Jun 2027 expected | sympathetic nervous system disorder | University of Missouri-Columbia | Recruiting | No outcome recorded |
| Phase 0 | NCT04821375 | Dec 2021 → May 2024 | — | Carol Fabian, MD | Completed | No outcome recorded |
| Phase 0 | NCT04379024 | Jun 2020 → Jul 2021 | — | Carol Fabian, MD | Terminated | No outcome recorded |
| Phase 114 trials | ||||||
| Phase 1 | NCT04478305 | Jul 2024 → Dec 2025 overdue | mixed anxiety and depressive disorder | St. Joseph's Healthcare Hamilton | Recruiting | No outcome recorded |
| Phase 1 | NCT01634789 | Aug → Nov 2012 | — | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01436513 | Oct 2011 → Mar 2012 | primary ovarian failure, vaginitis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00745173 | Sep → Oct 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00706225 | Jun → Jul 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00630435 | Feb → Jun 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00550303 | Oct → Nov 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00479778 | Apr → Jul 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00464789 | Mar → May 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00465075 | Mar → Apr 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00401219 | Nov 2006 → Feb 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00367536 | Aug 2006 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00318318 | Mar → Dec 2006 | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 1 | NCT00167921 | Oct 2005 → ? | postmenopausal atrophic vaginitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 211 trials · 1 missed | ||||||
| Phase 2 | NCT07466498 | Nov 2026 → Jun 2029 expected | metastatic prostate carcinoma, prostate adenocarcinoma | Fred Hutchinson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05073237 | Apr 2024 | obesity disorder, prediabetes syndrome | VA Office of Research and Development | Withdrawn | No outcome recorded |
| Phase 2 | NCT04821141 | Dec 2021 → Jul 2026 overdue | breast cancer | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00973674 | Jul 2009 → Jan 2012 | traumatic brain injury | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00973102 | Jul 2009 → Jan 2012 | — | University of Texas Southwestern Medical Center | Completed | Missed primary |
| Phase 2 | NCT00604825 | Jul 2007 → Jul 2008 | — | GlaxoSmithKline | Completed | Mixed |
| Phase 2 | NCT00149604 | Mar 2000 → Feb 2006 | — | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 2 | NCT00006399 | Sep 1999 → Mar 2004 | Alzheimer disease | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2 | NCT00001752 | Sep 1998 → Jul 2000 | hyperlipidemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00000612 | Jan 1996 → Dec 1998 | endometrial disorder, heart disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00005768 | — | — | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00310791 | Apr 2004 → Oct 2009 | anorexia nervosa | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT00386022 | Jan 2002 → Jan 2012 | — | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 314 trials · 2 met primary | ||||||
| Phase 3 | NCT06351501 | Jun 2024 → Jun 2029 expected | body integrity dysphoria | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT00808132 | Jan 2009 → Feb 2011 | osteoporosis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00234819 | Oct 2005 → Feb 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00675688 | Apr 2002 → Jan 2006 | endometrial disorder, osteoporosis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00026286 | Nov 2000 → Aug 2002 | breast cancer | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00002976 | Jun 1997 → Jul 2006 | endometrial cancer | Gynecologic Oncology Group | Terminated | No outcome recorded |
| Phase 3 | NCT00000555 | Aug 1996 → May 2003 | coronary atherosclerosis, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000419 | Apr 1996 → Aug 2002 | systemic lupus erythematosus | NYU Langone Health | Terminated | Met primary |
| Phase 3 | NCT00000177 | Oct 1995 → Jan 1999 | Alzheimer disease | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 3 | NCT00004650 | Aug 1993 → ? | osteoporosis | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 3 | NCT00319566 | Jul 1992 → Jul 2001 | coronary artery disorder | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT00000466 | Sep 1987 → Oct 2000 | coronary artery disorder, diabetes mellitus, hyperlipoproteinemia, hypertensive disorder +3 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000482 | Apr 1965 → Mar 1985 | coronary artery disorder, myocardial infarction, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000176 | ? → Sep 2007 | Alzheimer disease | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 411 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT03996603 | Aug 2019 → Jan 2021 | postmenopausal atrophic vaginitis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT02431897 | Dec 2016 → Nov 2021 | midline cystocele, pelvic organ prolapse | University of Texas Southwestern Medical Center | Completed | Missed primary |
| Phase 4 | NCT02860897 | Jul 2016 → Apr 2017 | — | University Hospitals Cleveland Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT02237079 | Dec 2014 → Apr 2018 | glucose metabolism disease, obesity disorder | Tulane University Health Sciences Center | Completed | No outcome recorded |
| Phase 4 | NCT02213757 | Aug 2014 → Dec 2015 | — | Medstar Health Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01886794 | Jun 2013 → Dec 2023 | pelvic organ prolapse | The University of Texas Medical Branch, Galveston | Terminated | No outcome recorded |
| Phase 4 | NCT01778985 | Dec 2012 → Mar 2013 | pelvic organ prolapse | University of Texas Southwestern Medical Center | Completed | Mixed |
| Phase 4 | NCT01613170 | Apr 2012 → Apr 2018 | overactive bladder | The Cleveland Clinic | Unknown | No outcome recorded |
| Phase 4 | NCT00276081 | May 2002 → Sep 2004 | — | University of Rochester | Completed | Met primary |
| Phase 4 | NCT00229450 | Apr 2002 → Aug 2003 | major depressive disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT00224094 | Jan 2002 → May 2003 | — | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable9 trials | ||||||
| — | NCT07821086 | Dec 2025 → Jul 2026 overdue | hypogonadism | Khyber Medical University Peshawar | Active not recruiting | No outcome recorded |
| — | NCT04036929 | May 2019 → Aug 2021 | osteoarthritis, hand | University of Oxford | Completed | No outcome recorded |
| — | NCT03578172 | Jul 2018 → Oct 2019 | adhesions of uterus, female infertility | Reproductive & Genetic Hospital of CITIC-Xiangya | Completed | No outcome recorded |
| — | NCT00680797 | Jan 2005 → Dec 2013 | — | VA Office of Research and Development | Completed | No outcome recorded |
| — | NCT00565916 | Aug 2004 → Jan 2008 | — | Washington University School of Medicine | Terminated | No outcome recorded |
| — | NCT00079248 | Mar 2002 → ? | breast cancer, osteoporosis | Institute of Cancer Research, United Kingdom | Unknown | No outcome recorded |
| — | NCT00004274 | Feb 1990 → ? | Turner syndrome | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| — | NCT00443716 | Apr 1985 → Apr 1989 | postmenopausal osteoporosis | Mayo Clinic | Completed | No outcome recorded |
| — | NCT00000175 | ? → Jun 2005 | cognitive disorder, mood disorder | National Institute on Aging (NIA) | Terminated | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 1 | NCT05118685 Comparator | Nov 2021 → Aug 2023 | postmenopausal atrophic vaginitis | Fayoum University | Unknown | No outcome recorded |
| Phase 1 | NCT00543634 Comparator | Oct → Dec 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00134654 Comparator | Mar 2003 → Jul 2005 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00152295 Background | Apr → Dec 2001 | — | Abbott | Completed | No outcome recorded |
| Phase 2 | NCT00152282 Comparator | Sep 2000 → Aug 2001 | amenorrhea | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT07030426 Comparator | Oct 2025 → Sep 2027 expected | pelvic organ prolapse | Queen's University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT00827151 Comparator | Dec 2008 → May 2011 | amenorrhea, osteoporosis | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03943823 Comparator | May 2019 → Mar 2021 | bacterial vaginosis, vaginal discharge | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03018106 Comparator | Jun → Sep 2017 | physiological sexual disorder | Emory University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03120715 Background | Jul 2016 → Jun 2017 | infertility disorder | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT00626340 Comparator | Jul 1999 → Jul 2008 | major depressive disorder | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT05302726 Comparator | Jan → Dec 2022 | adrenocortical insufficiency, hypogonadism | Rigshospitalet, Denmark | Unknown | No outcome recorded |
| — | NCT05464654 Comparator | Jun → Nov 2021 | postmenopausal atrophic vaginitis | Hospital Regional 1o de Octubre | Completed | No outcome recorded |
| — | NCT02691936 Comparator | Mar 2016 → Dec 2018 | postmenopausal atrophic vaginitis | The Cleveland Clinic | Completed | No outcome recorded |
| — | NCT01843166 Comparator | Jul 2012 → Dec 2016 | infective vaginitis, urinary tract infection | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| — | NCT01123135 Comparator | Jul 2009 → May 2010 | female stress incontinence | University of California, Irvine | Withdrawn | No outcome recorded |
| — | NCT01023178 Comparator | Feb 2007 → Jun 2013 | primary ovarian failure | Stanford University | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-06-30 | Eisai Inc. | EISAI TRANSFERS ALL FUTURE ECONOMIC RIGHTS FOR ELACESTRANT, A SELECTIVE ESTROGEN RECEPTOR DEGRADER, TO DRI HEALTHCARE eisai.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 81 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | conjugated estrogens | “Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)” NCT00310791 ↗31“Conjugated estrogens/bazedoxifene (CE/BZA) reduced menopause-related hot flashes (HFs) in the Selective estrogens, Menopause, And Response to Therapy (SMART) trials.” PMID 27676118 ↗ Sep 2016 “A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer” NCT00134654 ↗ “Duavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg)” NCT04379024 ↗ “Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.” NCT04478305 ↗ “conjugated equine estrogen cream (Premarin, 0.625mg conjugated estrogens)” NCT02213757 ↗ “Conjugated estrogens 0.45 mg-bazedoxifene acetate 20 mg.” NCT04036929 ↗ “Conjugated Estrogens CSD, 0.625 mg/g, Vaginal Cream” NCT07030426 ↗ “Premarin (conjugated estrogens or CE)” NCT00745173 ↗ |
| Known as | CEE | “conjugated equine estrogen (CEE), 0.625 milligrams per day” NCT00000466 ↗ |
| Known as | conjugated equine estrogen | “conjugated equine estrogen (CEE), 0.625 milligrams per day” NCT00000466 ↗ |
| Known as | Conjugated estrogen | “Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.” NCT05464654 ↗ |
| Known as | Conjugated Estrogens CSD, 0.625 mg/g, Vaginal Cream | “Conjugated Estrogens CSD, 0.625 mg/g, Vaginal Cream” NCT07030426 ↗ |
| Known as | conjugated estrogens/bazedoxifene (CE/BZA) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05073237 ↗ |
| Known as | ESTREVA | “4 years of follow up (FU) with evaluation at T0 (14 years old +/- 6 months), T1 (16 years old +/-6 months) and T2 (18 years old+/- 6 months) with eather ANDROGEL® 16.2 mg/g,...” NCT06351501 ↗ |
| Known as | Estrogen | “17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily” NCT03578172 ↗ |
| Known as | estrogens, conjugated | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00000612 ↗ |
| Known as | OCEE | “The purpose of this study was to compare the differential effects of treatment with oral conjugated equine estrogen (OCEE), oral 17β estradiol (OBE), or transdermal 17β...” PMID 24982681 ↗ Jun 2014 |
| Known as | oestrogenes | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06351501 ↗ |
| Known as | Premarin | “The placebo cream will be a pharmacologically inert formulation which will be packaged similarly to the active premarin cream and visually indistinguishable from the active...” NCT01123135 ↗24“Hormone replacement therapy consisted of estrogen plus a progestin (PremPro) for all gynecologically intact women, and unopposed estrogen (Premarin) for women with hysterectomies.” NCT00000555 ↗ “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.” NCT03943823 ↗ “Arm I: Patients receive oral conjugated estrogens (Premarin) daily for 3 years.” NCT00002976 ↗ “conjugated equine estrogen cream (Premarin, 0.625mg conjugated estrogens)” NCT02213757 ↗ “PREMARIN® (conjugated estrogens \[CE\]) is approved by FDA” NCT00706225 ↗ |
| Known as | Premarin (conjugated estrogens) | “Premarin (conjugated estrogens)” NCT00310791 ↗ |
| Known as | PROVAMES | “4 years of follow up (FU) with evaluation at T0 (14 years old +/- 6 months), T1 (16 years old +/-6 months) and T2 (18 years old+/- 6 months) with eather ANDROGEL® 16.2 mg/g,...” NCT06351501 ↗ |
| Known as | œstrogenes | “Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months” NCT06351501 ↗ |
| Action | Activate | “The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen.” NCT00000177 ↗ |
| Modality | Other / unclassified | “Conjugated estrogens are a mixture of several different estrogen salts derived from natural sources” NCT03018106 ↗ |
| Route | Oral | “Arm I: Patients receive oral conjugated estrogens (Premarin) daily for 3 years.” NCT00002976 ↗ |