Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flushes
Intervention: 2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch and a 1mg 17 Beta-estradiol transdermal patch (Drug)
Phase: Phase 4
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Berlex, Inc. Medical Affairs, Study Director, Affiliation: 1-888-BERLEX4
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
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Lowest effective dose in decreasing the frequency and severity of hot flushes
Secondary outcome: Other symptoms related to menopause
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.
Minimum age: 40 Years.
Maximum age: N/A.
- 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)
- Hormonal treatment
- contraindication to estrogen/progestogen therapy
Locations and Contacts
Starting date: December 2004
Last updated: April 30, 2007