Status:
COMPLETED
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Lead Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborating Sponsors:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
Brief Summary
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is re...
Detailed Description
Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenon...
Eligibility Criteria
Inclusion
- First-ever OC users ("starters")
- Women switching OC use without a pill intake break ("switchers")
- Recurrent users with a pill intake break ("recurrent users")
- Women willing to participate in the active surveillance
Exclusion
- Women who do not agree to participate
- Long-term users
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
85109 Patients enrolled
Trial Details
Trial ID
NCT00335257
Start Date
August 1 2005
End Date
March 1 2013
Last Update
August 7 2019
Active Locations (1)
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1
Center for Epidemiology and Health Research
Berlin, Germany, 10115