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
- 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
Vaginal Estrogen With Pessary Treatment
- Conditions
- Vaginal InfectionUrinary Tract InfectionQuality of Life
- Interventions
- Drug: Placebo cream
- First Posted Date
- 2013-04-30
- Last Posted Date
- 2018-11-06
- Lead Sponsor
- Lawson Health Research Institute
- Target Recruit Count
- 150
- Registration Number
- NCT01843166
- Locations
- šØš¦
London Health Sciences Centre, University of Western Ontario, London, Ontario, Canada
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
- 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
- šŗšø
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Premarin Versus Toviaz for Treatment of Overactive Bladder
- 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
- šŗšø
Cleveland Clinic Florida, Weston, Florida, United States
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
- Conditions
- MenopauseMetrorrhagiaPrimary Ovarian InsufficiencyVaginitis
- Interventions
- First Posted Date
- 2011-09-19
- Last Posted Date
- 2012-03-15
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 72
- Registration Number
- NCT01436513
- Locations
- šÆšµ
Pfizer Investigational Site, Shinjyuku-ku, Tokyo, Japan
Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
- 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
- šŗšø
Warner Chilcott Investigational Site, Tacoma, Washington, United States
Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
- Conditions
- Ovarian Failure, Premature
- Interventions
- Drug: 17Beta Estradiol - transdermal
- First Posted Date
- 2009-12-02
- Last Posted Date
- 2017-01-20
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 20
- Registration Number
- NCT01023178
- Locations
- šŗšø
Stanford University School of Medicine, Stanford, California, United States
Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury
- First Posted Date
- 2009-09-09
- Last Posted Date
- 2019-11-12
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Target Recruit Count
- 50
- Registration Number
- NCT00973674
- Locations
- šŗšø
Baylor University Medical Center, Dallas, Texas, United States
šŗšøParkland Hospital, Dallas, Texas, United States
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)
- First Posted Date
- 2009-09-09
- Last Posted Date
- 2020-03-19
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Target Recruit Count
- 50
- Registration Number
- NCT00973102
- Locations
- šŗšø
Parkland Hospital, Dallas, Texas, United States
šŗšøBaylor University Medical Center, Dallas, Texas, United States
Study Evaluating Premarin and Bazedoxifene Potential Interaction
- 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
- šŗšø
Dr. David Carter, Austin, Texas, United States
Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)
- 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
- š¬š§
GSK Investigational Site, Waterloo, Liverpool, United Kingdom
Drug Development Updates
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