Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

Phase 4CompletedNCT00195455

Wyeth is now a wholly owned subsidiary of Pfizer133 enrolled

Overview

The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

Postmenopause

Interventions

TrimegestoneDRUG

17b EstradiolDRUG

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day * Intact uterus Exclusion Criteria: * Known or suspected breast carcinoma or estrogen-dependent neoplasm * Undiagnosed abnormal genital bleeding

Locations (6)

Unnamed facility

Guadalajara, Jalisco, Mexico

Unnamed facility

Monterrey, N.L., Mexico

Unnamed facility

Monterrey, N.L., Mexico

Unnamed facility

Mexico City, Mexico

Unnamed facility

Outcomes

Primary Outcomes

To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.

Secondary Outcomes

Study bleeding patterns throughout the treatment period (6 months)

Evaluate changes in the Menopause-Specific Quality of Life Questionnaire

Data from ClinicalTrials.gov

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