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

Phase 2TerminatedNCT00141544

Solvay Pharmaceuticals28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Menopause

Interventions

esterified estrogens 1.25 mg and methyltestosterone 2.5 mgDRUG

ESTRATEST® administered orally QD

Esterified estrogens 1.25 mgDRUG

Esterified estrogens 1.25 mg administered orally QD

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Non-hysterectomized, menopausal women between the ages of 35 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 (78)

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

Change from baseline in the domain and individual item scores of the MRS

Time frame: 12 weeks

Change from baseline in the domain scores of the MENQOL

Time frame: monthly for 3 months

Comparison of changes in hormone levels and correlation with changes in the MRS

Time frame: 12 weeks

Data from ClinicalTrials.gov

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