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

Phase 4

Completed

• Conditions: Hot Flashes
• Interventions: Drug: Menostar (Estradiol transdermal); Drug: Climara PRO (Estradiol / Levonorgestrel transdermal); Drug: Placebo transdermal

• Registration Number: NCT00206622
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Study Completion: 2006-02
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-28
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 425

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Menostar (Estradiol transdermal)	-
Arm 1	Climara PRO (Estradiol / Levonorgestrel transdermal)	-
Arm 3	Placebo transdermal	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Other symptoms related to menopause