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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00206622
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 29, 2009
Sponsor:
Information provided by:
Bayer

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.

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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


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




Primary Outcome Measures :
  1. Lowest effective dose in decreasing the frequency and severity of hot flushes

Secondary Outcome Measures :
  1. Other symptoms related to menopause


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

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