Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes
NCT ID: NCT00206622
Last Updated: 2009-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
425 participants
INTERVENTIONAL
2004-12-31
2006-02-28
Brief Summary
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Detailed Description
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Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Climara PRO (Estradiol / Levonorgestrel transdermal)
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Arm 2
Menostar (Estradiol transdermal)
1mg 17 Beta-estradiol transdermal patch
Arm 3
Placebo transdermal
Placebo
Interventions
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Climara PRO (Estradiol / Levonorgestrel transdermal)
2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Menostar (Estradiol transdermal)
1mg 17 Beta-estradiol transdermal patch
Placebo transdermal
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindication to estrogen/progestogen therapy
40 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare Pharmaceuticals, Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Huntsville, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fair Oaks, California, United States
Oakland, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
New Britain, Connecticut, United States
West Hartford, Connecticut, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Alpharetta, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
South Bend, Indiana, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Reno, Nevada, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
Arlington, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Countries
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References
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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. doi: 10.1097/01.AOG.0000284450.51264.31.
Other Identifiers
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308261
Identifier Type: -
Identifier Source: secondary_id
91429
Identifier Type: -
Identifier Source: org_study_id