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

May 28, 2009 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

425

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Phoenix, Arizona, United States, 85031
      • Tucson, Arizona, United States, 85712
    • California
      • Fair Oaks, California, United States, 95628
      • Oakland, California, United States, 94612
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
    • Connecticut
      • New Britain, Connecticut, United States, 06050
      • West Hartford, Connecticut, United States, 06117
    • Florida
      • Fort Myers, Florida, United States, 33916
      • Gainesville, Florida, United States, 32610-0254
      • Jacksonville, Florida, United States, 32216
      • Tampa, Florida, United States, 33613
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Alpharetta, Georgia, United States, 30005
    • Idaho
      • Boise, Idaho, United States, 83702
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Champaign, Illinois, United States, 61820
      • Chicago, Illinois, United States, 60612
      • Peoria, Illinois, United States, 61615
    • Indiana
      • South Bend, Indiana, United States, 46601
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
      • New Orleans, Louisiana, United States, 70118-1034
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45236
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43213
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15206
    • Tennessee
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Arlington, Texas, United States, 76012
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77004
      • Temple, Texas, United States, 76502-1896
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Vermont
      • Burlington, Vermont, United States, 05401-1420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 2
Drug: Menostar (Estradiol transdermal)
1mg 17 Beta-estradiol transdermal patch
ACTIVE_COMPARATOR: Arm 1
Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
PLACEBO_COMPARATOR: Arm 3
Drug: Placebo transdermal
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lowest effective dose in decreasing the frequency and severity of hot flushes

Secondary Outcome Measures

Outcome Measure
Other symptoms related to menopause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2009

Last Update Submitted That Met QC Criteria

May 28, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91429
  • 308261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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