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 84 · started per year
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 1/21 trial | ||||||
| Phase 1/2 | NCT03663543 Comparator | Aug 2016 → Jan 2027 expected | ischemic disease | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT00420342 Comparator | Jan 2007 → Sep 2008 | hypertensive disorder | Bayer | 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 34 trials | ||||||
| Phase 3 | NCT07030426 Comparator | Oct 2025 → Sep 2027 expected | pelvic organ prolapse | Queen's University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT00803335 Comparator | Dec 2008 → May 2011 | pelvic organ prolapse, postmenopausal atrophic vaginitis | TriHealth Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00827151 Comparator | Dec 2008 → May 2011 | amenorrhea, osteoporosis | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT03097120 Comparator | Jan 1995 → Jan 2001 | heart disorder | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT03943823 Comparator | May 2019 → Mar 2021 | bacterial vaginosis, vaginal discharge | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded |
| Phase 4 | NCT03018106 Comparator | Jun → Sep 2017 | physiological sexual disorder | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT03120715 Background | Jul 2016 → Jun 2017 | infertility disorder | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT03032848 Comparator | Nov 2013 → Dec 2016 | endometrial disorder, pelvic organ prolapse, postmenopausal atrophic vaginitis | Federal University of Paraná | Completed | No outcome recorded |
| Phase 4 | NCT00626340 Comparator | Jul 1999 → Jul 2008 | major depressive disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT06144814 Comparator | Apr → Sep 2023 | postmenopausal atrophic vaginitis | Koru Health Groups | 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 |
| — | NCT04301934 Comparator | Jun 2020 → Apr 2023 | urinary tract infection | Mayo Clinic | 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 |
|---|---|---|
| 2017-07-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces the Launch of Generic Vagifem® in the United States tevapharm.com ↗ |
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 111 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 | “Study participants were 256 women who completed the Estrogen Replacement and Atherosclerosis (ERA) trial, a placebo-controlled, randomized trial that examined the effects of...” PMID 19155011 ↗ Dec 20083“conjugated equine estrogen (CEE), 0.625 milligrams per day” NCT00000466 ↗ “the use of conjugated equine estrogens (CEE) or placebo” PMID 27427235 ↗ Jul 2016 “vaginal conjugated equine estrogen (CEE) 0.625 mg” NCT06197295 ↗ |
| Known as | conjugated equine estrogen | “Study participants were 256 women who completed the Estrogen Replacement and Atherosclerosis (ERA) trial, a placebo-controlled, randomized trial that examined the effects of...” PMID 19155011 ↗ Dec 200811“A total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus...” NCT04103476 ↗ “1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)” NCT00420342 ↗ “conjugated equine estrogen 0.625 mg +/- 2.5 mg medroxyprogesterone acetate” PMID 16186076 ↗ Oct 2005 “Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg” NCT06197295 ↗ “Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).” NCT06479720 ↗ “conjugated equine estrogen (CEE), 0.625 milligrams per day” NCT00000466 ↗ |
| Known as | conjugated equine estrogens | “the use of conjugated equine estrogens (CEE) or placebo” PMID 27427235 ↗ Jul 2016 |
| Known as | Conjugated estrogen | “Subjects with rest angina and no contraindications to hormone therapy were randomized to receive intravenous followed by oral conjugated estrogen for 21 days, intravenous...” NCT00000601 ↗15“This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.” NCT00137371 ↗ “Subjects were randomized to conjugated estrogen with daily medroxyprogesterone or placebo within two weeks of bypass surgery.” NCT00000605 ↗ “Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram)” NCT02835846 ↗ “Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.” NCT05464654 ↗ “Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))” NCT02729701 ↗ “30 days of bazedoxifene + conjugated estrogen (0.45mg/20mg/day)” NCT05059626 ↗ |
| 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 | estrodiol | “Group I received 25 µg vaginal estrodiol (Vagifem®).” NCT06144814 ↗ |
| 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 NCT02691936 ↗ |
| Known as | Estrogens, Conjugated (USP) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01482416 ↗ |
| 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 primary objective is to describe the bacterial communities associated in the vagina and urine of postmenopausal women receiving treatment for genitourinary syndrome of...” NCT02869165 ↗26“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 ↗ “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, vaginal conjugated equine estrogen vaginal cream (0.625 mg).” NCT06479720 ↗ “PREMARIN® (conjugated estrogens \[CE\]) is approved by FDA” NCT00706225 ↗ |
| Known as | Premarin (conjugated estrogens) | “Premarin (conjugated estrogens)” NCT00310791 ↗ |
| Known as | Premarin cream | “We analyzed data from postmenopausal participants in 2 trials (NCT02524769 and NCT02835846) who chose vaginal estrogen as the primary overactive bladder treatment and used 0.5...” PMID 32791124 ↗ Aug 2020 |
| 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 | PVC | “This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.” NCT00137371 ↗ |
| Known as | Vagifem | “Group I received 25 µg vaginal estrodiol (Vagifem®).” NCT06144814 ↗ |
| 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 | Intravenous | “receive intravenous followed by oral conjugated estrogen” NCT00000601 ↗ |
| Route | Oral | “receive intravenous followed by oral conjugated estrogen” NCT00000601 ↗ |