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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hot Flashes

Intervention: Climara PRO (Estradiol / Levonorgestrel transdermal) (Drug); Menostar (Estradiol transdermal) (Drug); Placebo transdermal (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.


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 and Contacts

Huntsville, Alabama 35801, United States

Chandler, Arizona 85225, United States

Phoenix, Arizona 85031, United States

Tucson, Arizona 85712, United States

Fair Oaks, California 95628, United States

Oakland, California 94612, United States

San Diego, California 92103, United States

San Diego, California 92108, United States

San Diego, California 92123, United States

New Britain, Connecticut 06050, United States

West Hartford, Connecticut 06117, United States

Fort Myers, Florida 33916, United States

Gainesville, Florida 32610-0254, United States

Jacksonville, Florida 32216, United States

Tampa, Florida 33613, United States

West Palm Beach, Florida 33409, United States

Alpharetta, Georgia 30005, United States

Boise, Idaho 83702, United States

Idaho Falls, Idaho 83404, United States

Champaign, Illinois 61820, United States

Chicago, Illinois 60612, United States

Peoria, Illinois 61615, United States

South Bend, Indiana 46601, United States

Lexington, Kentucky 40536, United States

New Orleans, Louisiana 70115, United States

New Orleans, Louisiana 70118-1034, United States

Detroit, Michigan 48201, United States

St. Louis, Missouri 63110, United States

Lincoln, Nebraska 68510, United States

Reno, Nevada 89502, United States

New Brunswick, New Jersey 08901, United States

Albuquerque, New Mexico 87102, United States

Winston-Salem, North Carolina 27103, United States

Cincinnati, Ohio 45236, United States

Cleveland, Ohio 44122, United States

Columbus, Ohio 43213, United States

Philadelphia, Pennsylvania 19114, United States

Pittsburgh, Pennsylvania 15206, United States

Memphis, Tennessee 38120, United States

Arlington, Texas 76012, United States

Houston, Texas 77004, United States

Houston, Texas 77030, United States

Temple, Texas 76502-1896, United States

Salt Lake City, Utah 84124, United States

Burlington, Vermont 05401-1420, United States

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Starting date: December 2004
Last updated: May 28, 2009

Page last updated: August 20, 2015

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