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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
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

Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer

Phase 3
Terminated
Conditions
Endometrial Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-04-11
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
2108
Registration Number
NCT00002976
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

🇺🇸

Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States

and more 145 locations

Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss

Phase 3
Completed
Conditions
Osteoporosis
First Posted Date
2000-02-25
Last Posted Date
2005-06-24
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Target Recruit Count
150
Registration Number
NCT00004650

Safety of Estrogens in Lupus: Hormone Replacement Therapy

Phase 3
Terminated
Conditions
Systemic Lupus Erythematosus
First Posted Date
1999-11-04
Last Posted Date
2013-05-03
Lead Sponsor
NYU Langone Health
Target Recruit Count
350
Registration Number
NCT00000419
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

🇺🇸

University of Chicago Pritzker School of Medicine, Chicago, Illinois, United States

🇺🇸

Univ. of Pittsburgh, Dept. of Rheumatology, Pittsburgh, Pennsylvania, United States

and more 13 locations

Postmenopausal Estrogen/Progestin Interventions (PEPI)

Phase 3
Completed
Conditions
Bone Diseases
Thrombosis
Postmenopause
Cardiovascular Diseases
Coronary Disease
Diabetes Mellitus
Heart Diseases
Hypercholesterolemia
Hypertension
Myocardial Ischemia
First Posted Date
1999-10-28
Last Posted Date
2016-05-13
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000466

Women's Angiographic Vitamin and Estrogen Trial (WAVE)

Phase 3
Completed
Conditions
Coronary Arteriosclerosis
Myocardial Ischemia
Postmenopause
Cardiovascular Diseases
Coronary Disease
Heart Diseases
First Posted Date
1999-10-28
Last Posted Date
2016-07-12
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000555

Soy Estrogen Alternative Study (SEA)

Phase 2
Completed
Conditions
Menopause
Endometrial Hyperplasia
Cardiovascular Diseases
Heart Diseases
Menopausal Complaints
Uterine Diseases
First Posted Date
1999-10-28
Last Posted Date
2016-05-13
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000612
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