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
PHASE2
30 participants
INTERVENTIONAL
2009-06-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Arm 1
Gestodene/EE Patch (BAY86-5016)
21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles
Arm 2
EE/Levonorgestrel (Microgynon, BAY86-4977)
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles
Interventions
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Gestodene/EE Patch (BAY86-5016)
21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles
EE/Levonorgestrel (Microgynon, BAY86-4977)
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles
Eligibility Criteria
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Inclusion Criteria
* Normal cervical smear not requiring further follow-up
* History of regular cyclic menstrual periods
* Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods
Exclusion Criteria
* Any diseases or conditions that can compromise the function of the body systems
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
18 Years
35 Years
FEMALE
Yes
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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Berlin, State of Berlin, Germany
Countries
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References
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Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2008-007024-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91557
Identifier Type: -
Identifier Source: org_study_id