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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

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

Heart and Estrogen-Progestin Replacement Study (HERS)

Phase 3
Completed
Conditions
Coronary Heart Disease
First Posted Date
2006-04-27
Last Posted Date
2006-04-27
Lead Sponsor
University of California, San Francisco
Target Recruit Count
2430
Registration Number
NCT00319566
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

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

POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease

Phase 2
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2005-10-07
Last Posted Date
2008-01-08
Lead Sponsor
The Parkinson Study Group
Target Recruit Count
23
Registration Number
NCT00234676
Locations
🇺🇸

The Parkinson's Institute, Sunnyvale, California, United States

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

and more 3 locations

A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women

Phase 4
Completed
Conditions
Menopause
Interventions
First Posted Date
2005-09-22
Last Posted Date
2012-10-15
Lead Sponsor
Watson Pharmaceuticals
Target Recruit Count
27
Registration Number
NCT00224094
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis

Phase 1
Completed
Conditions
Atrophic Vaginitis
First Posted Date
2005-09-14
Last Posted Date
2007-05-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
24
Registration Number
NCT00167921

AFTER: Altering Fat Through Estrogen and Raloxifene

Phase 2
Completed
Conditions
Postmenopause
First Posted Date
2005-09-08
Last Posted Date
2009-12-02
Lead Sponsor
National Institute on Aging (NIA)
Target Recruit Count
108
Registration Number
NCT00149604
Locations
🇺🇸

University of Colorado at Denver and Health Sciences Center, Denver, Colorado, United States

Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-08-25
Last Posted Date
2011-06-16
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
48
Registration Number
NCT00134654
Locations
🇺🇸

Dana-Farber Cancer Insitute, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer

Not Applicable
Conditions
Breast Cancer
Hot Flashes
Menopausal Symptoms
Osteoporosis
First Posted Date
2004-03-10
Last Posted Date
2009-05-12
Lead Sponsor
Institute of Cancer Research, United Kingdom
Registration Number
NCT00079248
Locations
🇬🇧

Institute of Cancer Research - UK, Sutton, England, United Kingdom

Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

Phase 3
Completed
Conditions
Hot Flashes
Breast Cancer
Menopausal Symptoms
First Posted Date
2003-09-17
Last Posted Date
2023-06-15
Lead Sponsor
Eastern Cooperative Oncology Group
Registration Number
NCT00026286
Locations
🇺🇸

CCOP - Carle Cancer Center, Urbana, Illinois, United States

🇺🇸

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

🇺🇸

CCOP - Northern New Jersey, Hackensack, New Jersey, United States

and more 21 locations
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