Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Phase 2CompletedNCT00141570

Solvay Pharmaceuticals350 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

350

Conditions

Menopause

Interventions

esterified estrogens 0.625 mg and methyltestosterone 1.25 mgDRUG

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (77)

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

Data from ClinicalTrials.gov

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