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

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ClinicalTrials.gov Identifier: NCT00206622

Recruitment Status : Completed

First Posted : September 21, 2005

Last Update Posted : May 29, 2009

Sponsor:

Information provided by:

Bayer

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Hot Flashes	Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) Drug: Menostar (Estradiol transdermal) Drug: Placebo transdermal	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	425 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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 Start Date :	December 2004
Actual Study Completion Date :	February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol Estradiol benzoate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm 1	Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) 2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Active Comparator: Arm 2	Drug: Menostar (Estradiol transdermal) 1mg 17 Beta-estradiol transdermal patch
Placebo Comparator: Arm 3	Drug: Placebo transdermal Placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Other symptoms related to menopause

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206622

Locations

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United States, Alabama

Huntsville, Alabama, United States, 35801
United States, Arizona

Chandler, Arizona, United States, 85225

Phoenix, Arizona, United States, 85031

Tucson, Arizona, United States, 85712
United States, 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
United States, Connecticut

New Britain, Connecticut, United States, 06050

West Hartford, Connecticut, United States, 06117
United States, 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
United States, Georgia

Alpharetta, Georgia, United States, 30005
United States, Idaho

Boise, Idaho, United States, 83702

Idaho Falls, Idaho, United States, 83404
United States, Illinois

Champaign, Illinois, United States, 61820

Chicago, Illinois, United States, 60612

Peoria, Illinois, United States, 61615
United States, Indiana

South Bend, Indiana, United States, 46601
United States, Kentucky

Lexington, Kentucky, United States, 40536
United States, Louisiana

New Orleans, Louisiana, United States, 70115

New Orleans, Louisiana, United States, 70118-1034
United States, Michigan

Detroit, Michigan, United States, 48201
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, Nebraska

Lincoln, Nebraska, United States, 68510
United States, Nevada

Reno, Nevada, United States, 89502
United States, New Jersey

New Brunswick, New Jersey, United States, 08901
United States, New Mexico

Albuquerque, New Mexico, United States, 87102
United States, North Carolina

Winston-Salem, North Carolina, United States, 27103
United States, Ohio

Cincinnati, Ohio, United States, 45236

Cleveland, Ohio, United States, 44122

Columbus, Ohio, United States, 43213
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19114

Pittsburgh, Pennsylvania, United States, 15206
United States, Tennessee

Memphis, Tennessee, United States, 38120
United States, Texas

Arlington, Texas, United States, 76012

Houston, Texas, United States, 77004

Houston, Texas, United States, 77030

Temple, Texas, United States, 76502-1896
United States, Utah

Salt Lake City, Utah, United States, 84124
United States, Vermont

Burlington, Vermont, United States, 05401-1420

Sponsors and Collaborators

Bayer

Investigators

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Study Director:	Bayer Study Director	Bayer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bachmann GA, Schaefers M, Uddin A, Utian WH. Lowest effective transdermal 17beta-estradiol dose for relief of hot flushes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):771-9.

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Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00206622
Other Study ID Numbers:	91429 308261
First Posted:	September 21, 2005 Key Record Dates
Last Update Posted:	May 29, 2009
Last Verified:	May 2009

Additional relevant MeSH terms:

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Hot Flashes Estradiol 17 beta-cypionate Estradiol 3-benzoate Levonorgestrel Estradiol Polyestradiol phosphate Estrogens Hormones	Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral

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