Status:
COMPLETED
FC Patch Low: Metabolism Study
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women...
Eligibility Criteria
Inclusion
- Healthy woman requesting contraception
- Normal cervical smear not requiring further follow-up
- History of regular cyclic menstrual periods
- Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods
Exclusion
- Pregnancy or lactation - Obesity (Body Mass Index \[BMI\] \> 30.0 kg/m2)
- Any diseases or conditions that can compromise the function of the body systems
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Any disease or condition that may worsen under hormonal treatment
- Undiagnosed abnormal genital bleeding
- Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00933179
Start Date
June 1 2009
End Date
September 1 2010
Last Update
November 14 2014
Active Locations (1)
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1
Berlin, State of Berlin, Germany, 10115