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Conjugated estrogens

Generic Name
Conjugated estrogens
Brand Names
Congest, Duavee, Duavive, Premarin, Premphase 28 Day, Prempro 0.625/2.5 28 Day
Drug Type
Small Molecule
Chemical Formula
-
CAS Number
12126-59-9
Unique Ingredient Identifier
IU5QR144QX
Background

The conjugated estrogens are noncrystalline mixtures of purified female sex hormones obtained either by its isolation from the urine of pregnant mares or by synthetic generation from vegetal material. Both of these products are later conjugated to natrium sulfate by ester bonds in order to make them more water soluble.

The conjugated estrogen product contains a mix of estrogen from which about 50% is represented by estrone sulfate followed by 25% of equilin sulfate, 15% of 17-alpha-dehydroequilenin sulfate, 3% of equilenin sulfate, 5% of 17-alpha and 17-beta-dihydroequilenin sulfate, 2% of 17-alpha-estradiolsulfate and 3% of 17-beta-estradiolsulfate. It also presents a large number of unidentified molecules with weak estrogenic activity as well as non-human molecules when it is obtained from pregnant mares urine.

The conjugated estrogen mixture was approved for marketing in US in 1942 based on the efficacy against certain conditions. However, until 1986 official clinical trials were performed and this product was determined to be effective for the treatment of osteoporosis. The currently approved product of conjugated estrogens was developed by Wyeth Ayerst and FDA approved in 2003.

Indication

The conjugated estrogens are indicated for several different conditions including:

Associated Conditions
Abnormal Uterine Bleeding, Atrophic Vaginitis, Atrophy of vulva, Kraurosis Vulvae, Menopause, Metastatic Breast Cancer, Moderate to Severe Vasomotor Symptoms, Osteoporosis, Androgen-dependent tumor Advanced Prostate Carcinoma, Hypoestrogenism, Moderate Dyspareunia, Moderate Vulvar and Vaginal Atrophy, Severe Dyspareunia, Severe Vulvar and Vaginal Atrophy
Associated Therapies
Estrogen Replacement Therapy, Palliative Treatment

Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery

Phase 4
Withdrawn
Conditions
Estrogen
Menopause
Pelvic Floor Disorders
Surgery
Interventions
First Posted Date
2016-08-09
Last Posted Date
2018-05-02
Lead Sponsor
University Hospitals Cleveland Medical Center
Registration Number
NCT02860897
Locations
🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2016-04-06
Last Posted Date
2022-03-09
Lead Sponsor
University of Kansas Medical Center
Target Recruit Count
28
Registration Number
NCT02729701
Locations
🇺🇸

University of Kansas Medical Center Breast Cancer Prevention Center, Westwood, Kansas, United States

🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor

Phase 4
Completed
Conditions
Pelvic Organ Prolapse
Menopause
Interventions
Drug: Premarin
Other: Placebo
First Posted Date
2013-01-29
Last Posted Date
2014-10-02
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
30
Registration Number
NCT01778985
Locations
🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

Premarin Versus Toviaz for Treatment of Overactive Bladder

Phase 4
Conditions
Overactive Bladder
Interventions
Drug: Toviaz
Drug: Premarin
Drug: Placebo cream
First Posted Date
2012-06-07
Last Posted Date
2017-04-20
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
90
Registration Number
NCT01613170
Locations
🇺🇸

Cleveland Clinic Florida, Weston, Florida, United States

Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

Phase 3
Completed
Conditions
Hormone Replacement Therapy
Interventions
First Posted Date
2010-02-18
Last Posted Date
2013-04-22
Lead Sponsor
Warner Chilcott
Target Recruit Count
249
Registration Number
NCT01070979
Locations
🇺🇸

Warner Chilcott Investigational Site, Tacoma, Washington, United States

Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure

Not Applicable
Completed
Conditions
Ovarian Failure, Premature
Interventions
First Posted Date
2009-12-02
Last Posted Date
2017-01-20
Lead Sponsor
Stanford University
Target Recruit Count
20
Registration Number
NCT01023178
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Study Evaluating Premarin and Bazedoxifene Potential Interaction

Phase 1
Completed
Conditions
Postmenopause
Interventions
First Posted Date
2008-09-03
Last Posted Date
2009-02-12
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
30
Registration Number
NCT00745173
Locations
🇺🇸

Dr. David Carter, Austin, Texas, United States

Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)

Phase 2
Completed
Conditions
Menopausal and Female Climacteric States
Interventions
First Posted Date
2008-01-30
Last Posted Date
2017-10-03
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
356
Registration Number
NCT00604825
Locations
🇬🇧

GSK Investigational Site, Waterloo, Liverpool, United Kingdom

Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

Completed
Conditions
Postmenopause
First Posted Date
2006-09-27
Last Posted Date
2006-09-27
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
54
Registration Number
NCT00380887

Beneficial Effects of Oral Premarin Estrogen Replacement Therapy Assessed by Human Genome Array

Phase 1
Completed
Conditions
Healthy
Estrogen Replacement Therapy
First Posted Date
2006-04-26
Last Posted Date
2009-07-09
Lead Sponsor
Lawson Health Research Institute
Target Recruit Count
20
Registration Number
NCT00318318
Locations
🇨🇦

Lawson Health Research Institute, London, Ontario, Canada

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