NCT00206622

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

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Climara PRO (Estradiol / Levonorgestrel transdermal)	2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
DRUG	Menostar (Estradiol transdermal)	1mg 17 Beta-estradiol transdermal patch
DRUG	Placebo transdermal	Placebo

Timeline

• Start date: 2004-12-01
• Completion: 2006-02-01
• First posted: 2005-09-21
• Last updated: 2009-05-29

Locations

45 sites across 1 country: United States