Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene
NCT ID: NCT00729404
Last Updated: 2014-12-02
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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TERMINATED
PHASE2
17 participants
INTERVENTIONAL
2008-08-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Ethinylestradiol/Gestodene (BAY86-5016)
transdermal patch: 0.55mg EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)
Arm 2
Ethinylestradiol/Gestodene (BAY86-5016)
transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles
Interventions
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Ethinylestradiol/Gestodene (BAY86-5016)
transdermal patch: 0.55mg EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)
Ethinylestradiol/Gestodene (BAY86-5016)
transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles
Eligibility Criteria
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Inclusion Criteria
* BMI: 18 - 30 kg/m²,
* Healthy female volunteers,
* Age 18-35 years (smoker not older than 30 years, inclusive),
* Ovulatory pre-treatment cycle, at least 3 month since delivery,
* Abortion or lactation before the first screening examination,
* Willingness to use non-hormonal methods of contraception during entire study
Exclusion Criteria
* Regular intake of medication other than OCs
* Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
* Anovulatory pre-treatment cycle
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
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Countries
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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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2008-001198-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91558
Identifier Type: -
Identifier Source: org_study_id