A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Solvay Pharmaceuticals77 sites in 1 country350 target enrollmentStarted: June 1, 2004Last updated: January 16, 2015

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: Solvay Pharmaceuticals
Enrollment: 350
Locations: 77
Primary Endpoint: Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 30 Years to 65 Years (Adult, Older Adult)
Sex: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

•Menopausal women between the ages of 30 and 65 years (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

Outcomes

Primary Outcomes

Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12

Secondary Outcomes

Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS

Investigators

Sponsor

Solvay Pharmaceuticals

Sponsor Class

Industry

Study Sites (77)

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