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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00185484 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Oral Contraceptive Study
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Scientific title:
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Multi-Center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-Cyclodextrin Clathrate and 3 mg Drospirenone in a 24-Day Regimen for 13 Cycles in 1010 Healthy Female Volunteers |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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1129 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00185484 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Belgium
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Czech Republic
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Hungary
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Italy
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Latvia
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Slovakia
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy woman requesting contraception
- Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)
Exclusion Criteria:
- Any conditions might interfere study outcome
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Contraception
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Intervention(s)
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Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
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Primary Outcome(s)
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Rate of unintended pregnancies (Pearl index)
[Time Frame: 13 cycles of 28 days]
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Secondary Outcome(s)
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Body weight
[Time Frame: each visit]
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Cervical smear
[Time Frame: each visit]
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Physical and gynecological examination
[Time Frame: screening, cycle 6 and final examination]
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Vital signs
[Time Frame: each visit]
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Secondary ID(s)
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308021
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91353
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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