The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

Phase 2

Terminated

• Conditions: Menopause
• Interventions: Drug: Esterified estrogens 1.25 mg; Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg

• Registration Number: NCT00141557
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2007-04
• Study Completion: 2008-03
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-10
• Last Update Posted: 2008-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 133

Inclusion Criteria

Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Esterified estrogens 1.25 mg	-
1	esterified estrogens 1.25mg and methyltestosterone 2.5mg	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the total score of the Menopause Rating Scale (MRS)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the domain and individual item scores of the MRS	12 weeks
Change from baseline in the domain scores of the MENQOL	monthly for 3 months
Comparison of changes in hormone levels and correlation with changes in the MRS	12 weeks

Trial Locations

Locations (78)

Site 66; 🇺🇸 Huntsville, Alabama, United States

Site 57; 🇺🇸 Mobile, Alabama, United States

Site 46; 🇺🇸 Montgomery, Alabama, United States

Site 29; 🇺🇸 Phoenix, Arizona, United States

Site 15; 🇺🇸 Tucson, Arizona, United States

Site 3; 🇺🇸 Jonesboro, Arkansas, United States

Site 22; 🇺🇸 Little Rock, Arkansas, United States

Site 68; 🇺🇸 Carmichael, California, United States

Site 55; 🇺🇸 Encinitas, California, United States

Site 6; 🇺🇸 San Diego, California, United States

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