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
PHASE3
187 participants
INTERVENTIONAL
2009-01-31
2011-01-31
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
TREATMENT
DOUBLE
Study Groups
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Arm 1
EE20/DRSP(YAZ, BAY86-5300)
20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Arm 2
Placebo
Inert tablet
Interventions
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EE20/DRSP(YAZ, BAY86-5300)
20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Placebo
Inert tablet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of sleeping medication (including melatonin) for more than 3 days per month.
* Pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment
* Obesity (body mass index or BMI \> 30 kg/m2)
* Hypersensitivity to any ingredient of the study drug
18 Years
45 Years
FEMALE
No
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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Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Wuhan, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Dalian, Liaoning, China
Jinan, Shandong, China
Xi’an, Shanxi, China
Xi’an, Shanxi, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Tianjin, , China
Countries
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Other Identifiers
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311962
Identifier Type: OTHER
Identifier Source: secondary_id
91771
Identifier Type: -
Identifier Source: org_study_id
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