Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
NCT ID: NCT00446199
Last Updated: 2015-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
735 participants
INTERVENTIONAL
2007-03-31
2008-11-30
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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0.5mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
0.5mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
Estradiol (E2 0.3mg)
One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).
Estradiol (E2 0.3mg)
One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).
Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Interventions
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0.5mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
Estradiol (E2 0.3mg)
One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).
Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Mobile, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Paramount, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Valley Village, California, United States
Vista, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
New Britain, Connecticut, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Lake Worth, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Arlington Heights, Illinois, United States
Champaign, Illinois, United States
La Grange Park, Illinois, United States
Newburgh, Indiana, United States
Lexington, Kentucky, United States
Amite, Louisiana, United States
Marrero, Louisiana, United States
Paw Paw, Michigan, United States
Chaska, Minnesota, United States
Springfield, Missouri, United States
Billings, Montana, United States
Billings, Montana, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Lawrenceville, New Jersey, United States
New Brunswick, New Jersey, United States
Princeton, New Jersey, United States
Albuquerque, New Mexico, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wexford, Pennsylvania, United States
Columbia, South Carolina, United States
Sioux Falls, South Dakota, United States
Chattanooga, Tennessee, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Burlington, Vermont, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Renton, Washington, United States
Seattle, Washington, United States
Countries
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References
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Sutter G, Schmelter T, Gude K, Schaefers M, Gerlinger C, Archer DF. Population pharmacokinetic/pharmacodynamic evaluation of low-dose drospirenone with 17beta-estradiol in postmenopausal women with moderate to severe vasomotor symptoms. Menopause. 2014 Mar;21(3):236-42. doi: 10.1097/GME.0b013e31829c12e8.
Archer DF, Schmelter T, Schaefers M, Gerlinger C, Gude K. A randomized, double-blind, placebo-controlled study of the lowest effective dose of drospirenone with 17beta-estradiol for moderate to severe vasomotor symptoms in postmenopausal women. Menopause. 2014 Mar;21(3):227-35. doi: 10.1097/GME.0b013e31829c1431.
K. Gude; T. Schmelter; M. Schaefers; C. Gerlinger. Efficacy of low dose Angeliq (0.5 mg E2 and 0.25 or 0.5 mg DRSP) compared to Angeliq (1 mg E2 and 1, 2 or 3 mg DRSP) in postmenopausal women with moderate to severe hot flushes. Menopause, Vol. 19, No. 12, 2012 * 2012, P-36, p 1388
Gerlinger C, Gude K, Hiemeyer F, Schmelter T, Schafers M. An empirically validated responder definition for the reduction of moderate to severe hot flushes in postmenopausal women. Menopause. 2012 Jul;19(7):799-803. doi: 10.1097/gme.0b013e31823de8ba.
Other Identifiers
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310184
Identifier Type: OTHER
Identifier Source: secondary_id
91493
Identifier Type: -
Identifier Source: org_study_id
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