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

Clinical Trials

Affect of Duavive on Mood & Anxiety Symptoms

Phase 1

Recruiting

Conditions: Menopause
Depression, Anxiety
Sleep
Menopause Related Conditions

Interventions: Drug: Duavive 0.45Mg-20Mg Tablet

First Posted Date: 2020-07-20

Last Posted Date: 2024-12-03

Lead Sponsor: St. Joseph's Healthcare Hamilton

Target Recruit Count: 30

Registration Number: NCT04478305

Locations: 🇨🇦
St Joseph's Healthcare, Hamilton, Ontario, Canada

Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms

Early Phase 1

Terminated

Conditions: Focus of Study is Healthy Women at Risk for Breast Cancer

Interventions: Drug: DUAVEE 0.45Mg-20Mg Tablet

First Posted Date: 2020-05-07

Last Posted Date: 2021-10-29

Lead Sponsor: Carol Fabian, MD

Target Recruit Count: 11

Registration Number: NCT04379024

Locations: 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States

Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy

Phase 4

Completed

Conditions: Postmenopausal Symptoms
Vaginal Atrophy
Female Urogenital Diseases
Postmenopausal Atrophic Vaginitis
Genitourinary Disease

Interventions: Drug: Conjugated Estrogens Cream

First Posted Date: 2019-06-25

Last Posted Date: 2024-05-07

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 25

Registration Number: NCT03996603

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

Impact of Estrogen + Estradiol Receptor Alpha Modulator Therapy on Oxidative Stress in Post-menopausal Women With and Without Sleep Apnea

Phase 3

Conditions: Sleep Apnea
Post Menopausal
Oxidative Stress

Interventions: Drug: Duavive (0.45 estrogens mg and 20 mg bazedoxifene)

First Posted Date: 2019-06-10

Last Posted Date: 2022-04-08

Lead Sponsor: Laval University

Target Recruit Count: 36

Registration Number: NCT03981341

Locations: 🇨🇦
IUCPQ, Quebec, Canada

Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?

Completed

Conditions: Pelvic Organ Prolapse
Postoperative Pain

Interventions: Drug: Premarin Vaginal cream
Drug: Bupivacaine

First Posted Date: 2017-08-30

Last Posted Date: 2019-08-08

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 140

Registration Number: NCT03266926

Locations: 🇨🇦
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

Phase 4

Terminated

Conditions: Sexual Dysfunction, Physiological

Interventions: Drug: Vaginal conjugated estrogens
Drug: Ospemifene

First Posted Date: 2017-01-11

Last Posted Date: 2018-01-23

Lead Sponsor: Emory University

Target Recruit Count: 1

Registration Number: NCT03018106

Locations: 🇺🇸
Emory Hospital, Atlanta, Georgia, United States
🇺🇸
Emory Midtown Hospital, Atlanta, Georgia, United States
🇺🇸
Emory Clinic, Atlanta, Georgia, United States

and more 1 locations

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

Phase 4

Withdrawn

Conditions: Estrogen
Menopause
Pelvic Floor Disorders
Surgery

Interventions: Drug: Premarin
Drug: Vagifem

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: Drug: Duavee

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

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

Phase 4

Completed

Conditions: Urogenital Prolapse
Vaginal Vault Prolapse
Pelvic Organ Prolapse
Cystocele
Uterine Prolapse
Vaginal Prolapse
Pelvic Floor Disorders

Interventions: Drug: Placebo Cream
Drug: Conjugated Estrogens Cream

First Posted Date: 2015-05-01

Last Posted Date: 2023-09-06

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 206

Registration Number: NCT02431897

Locations: 🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)

Phase 4

Terminated

Conditions: Microscopic Hematuria

Interventions: Drug: Placebo vaginal cream
Drug: Premarin vaginal estrogen cream

First Posted Date: 2014-08-11

Last Posted Date: 2023-03-15

Lead Sponsor: Medstar Health Research Institute

Target Recruit Count: 29

Registration Number: NCT02213757

Locations: 🇺🇸
MedStar Washington Hospital Center, Washington, District of Columbia, United States

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