Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.
NCT ID: NCT01204190
Last Updated: 2014-11-04
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
173 participants
INTERVENTIONAL
2010-09-30
2011-08-31
Brief Summary
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With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm 1
Gestodene/EE Patch (BAY86-5016)
0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Arm 2
Gestodene/EE Patch (BAY86-5016)
0.35 mg ethinyl estradiol (EE) + 0.67 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Arm 3
Gestodene/EE Patch (BAY86-5016)
0.275 mg ethiny estradiol (EE) + 1.05 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Interventions
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Gestodene/EE Patch (BAY86-5016)
0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Gestodene/EE Patch (BAY86-5016)
0.35 mg ethinyl estradiol (EE) + 0.67 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Gestodene/EE Patch (BAY86-5016)
0.275 mg ethiny estradiol (EE) + 1.05 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
Eligibility Criteria
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Inclusion Criteria
* age 18 - 35 years (smoker not older than 30 years, inclusive)
* ovulatory pre-treatment cycle
Exclusion Criteria
* Regular intake of medication other than Oral Contraception
* Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
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
Groningen, , Netherlands
Countries
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Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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2010-021255-81
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15264
Identifier Type: -
Identifier Source: org_study_id
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