A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
NCT ID: NCT00631124
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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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2008-02-29
2008-12-31
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
PREVENTION
DOUBLE
Study Groups
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Arm 1
BAY86-4891 (Estradiol / Drospirenone)
Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Arm 2
BAY86-4891 (Estradiol / Drospirenone)
Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Interventions
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BAY86-4891 (Estradiol / Drospirenone)
Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
BAY86-4891 (Estradiol / Drospirenone)
Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Eligibility Criteria
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Inclusion Criteria
* Age 18 - 35 years
Exclusion Criteria
* Regular intake of medication
* Clinically relevant findings (ECG, blood pressure, physical, gynecological 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
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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2007-004544-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
311623
Identifier Type: OTHER
Identifier Source: secondary_id
91697
Identifier Type: -
Identifier Source: org_study_id