Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes

Phase 4CompletedNCT00206622

Bayer425 enrolled

Overview

To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

425

Conditions

Hot Flashes

Interventions

Climara PRO (Estradiol / Levonorgestrel transdermal)DRUG

2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch

Menostar (Estradiol transdermal)DRUG

1mg 17 Beta-estradiol transdermal patch

Placebo transdermalDRUG

Placebo

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Menopause * Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days) Exclusion Criteria: * Hormonal treatment * Contraindication to estrogen/progestogen therapy

Locations (45)

Outcomes

Primary Outcomes

Lowest effective dose in decreasing the frequency and severity of hot flushes

Secondary Outcomes

Other symptoms related to menopause

Data from ClinicalTrials.gov

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Unnamed facility

Huntsville, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Fair Oaks, California, United States

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Oakland, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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New Britain, Connecticut, United States

...and 35 more locations