- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00206622
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
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
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Alabama
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Huntsville, Alabama, United States, 35801
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Arizona
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Chandler, Arizona, United States, 85225
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Phoenix, Arizona, United States, 85031
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Tucson, Arizona, United States, 85712
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California
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Fair Oaks, California, United States, 95628
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Oakland, California, United States, 94612
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San Diego, California, United States, 92103
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San Diego, California, United States, 92108
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San Diego, California, United States, 92123
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Connecticut
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New Britain, Connecticut, United States, 06050
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West Hartford, Connecticut, United States, 06117
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Florida
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Fort Myers, Florida, United States, 33916
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Gainesville, Florida, United States, 32610-0254
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Jacksonville, Florida, United States, 32216
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Tampa, Florida, United States, 33613
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West Palm Beach, Florida, United States, 33409
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Georgia
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Alpharetta, Georgia, United States, 30005
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Idaho
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Boise, Idaho, United States, 83702
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Idaho Falls, Idaho, United States, 83404
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Illinois
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Champaign, Illinois, United States, 61820
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Chicago, Illinois, United States, 60612
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Peoria, Illinois, United States, 61615
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Indiana
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South Bend, Indiana, United States, 46601
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Kentucky
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Lexington, Kentucky, United States, 40536
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Louisiana
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New Orleans, Louisiana, United States, 70115
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New Orleans, Louisiana, United States, 70118-1034
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Michigan
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Detroit, Michigan, United States, 48201
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Missouri
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St. Louis, Missouri, United States, 63110
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Nebraska
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Lincoln, Nebraska, United States, 68510
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Nevada
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Reno, Nevada, United States, 89502
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New Jersey
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New Brunswick, New Jersey, United States, 08901
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New Mexico
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Albuquerque, New Mexico, United States, 87102
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Cincinnati, Ohio, United States, 45236
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Cleveland, Ohio, United States, 44122
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Columbus, Ohio, United States, 43213
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19114
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Pittsburgh, Pennsylvania, United States, 15206
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Tennessee
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Memphis, Tennessee, United States, 38120
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Texas
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Arlington, Texas, United States, 76012
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77004
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Temple, Texas, United States, 76502-1896
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Utah
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Salt Lake City, Utah, United States, 84124
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Vermont
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Burlington, Vermont, United States, 05401-1420
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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 |
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ACTIVE_COMPARATOR: Arm 2
|
1mg 17 Beta-estradiol transdermal patch
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ACTIVE_COMPARATOR: Arm 1
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2.2mg 17 Beta-estradiol/0.69mg
levonorgestrel combination transdermal patch
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PLACEBO_COMPARATOR: Arm 3
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Lowest effective dose in decreasing the frequency and severity of hot flushes
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Secondary Outcome Measures
Outcome Measure |
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Other symptoms related to menopause
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
- Hot Flashes
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Levonorgestrel
- Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
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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