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

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

Status: Completed

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

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.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Starting date: December 2004
Last updated: April 30, 2007