Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
662 participants
INTERVENTIONAL
2007-08-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
0.5mg NETA / 1.0mg E2 (Activella)
One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).
0.5mg NETA / 1.0mg E2 (Activella)
One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).
Interventions
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0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
0.5mg NETA / 1.0mg E2 (Activella)
One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).
Eligibility Criteria
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Inclusion Criteria
* Non-hysterectomized women.
40 Years
65 Years
FEMALE
No
Sponsors
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Laboratorium für Klinische Forschung
UNKNOWN
Diagnostic Cytology Laboratory
UNKNOWN
University of California, San Francisco
OTHER
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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Chandler, Arizona, United States
San Diego, California, United States
San Diego, California, United States
Denver, Colorado, United States
Greenwood Village, Colorado, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Boise, Idaho, United States
Amite, Louisiana, United States
Marrero, Louisiana, United States
Las Vegas, Nevada, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Corpus Christi, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Lanús Oeste, Buenos Aires, Argentina
San Isidro, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Mödling, Lower Austria, Austria
Wiener Neustadt, Lower Austria, Austria
Fürstenfeld, Styria, Austria
Wörgl, Tyrol, Austria
Bregenz, Vorarlberg, Austria
Innsbruck, , Austria
Klagenfurt, , Austria
Mürzzuschlag, , Austria
Sankt Pölten, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Zeltweg, , Austria
Goiânia, Goiás, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Aalborg, , Denmark
Ballerup Municipality, , Denmark
Vejle, , Denmark
Bologna, , Italy
Cagliari, , Italy
Modena, , Italy
Novara, , Italy
Parma, , Italy
Pisa, , Italy
Sassari, , Italy
Siena, , Italy
Mexico City, Mexico City, Mexico
México, , Mexico
México, D.F., , Mexico
Monterrey, , Mexico
Moscow, , Russia
Moscow, , Russia
Moskva, , Russia
Moskva, , Russia
Moskva, , Russia
Countries
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References
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Genazzani AR, Schmelter T, Schaefers M, Gerlinger C, Gude K. One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17beta-estradiol in postmenopausal women. Climacteric. 2013 Aug;16(4):490-8. doi: 10.3109/13697137.2013.783797. Epub 2013 May 11.
Related Links
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click here and search for Bayer Product information provided by the EMA
Other Identifiers
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2006-006199-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
310523
Identifier Type: OTHER
Identifier Source: secondary_id
91508
Identifier Type: -
Identifier Source: org_study_id