Status:
COMPLETED
EU/LA Pearl Index Study - Transdermal Contraceptive Patch
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
Eligibility Criteria
Inclusion
- Requiring contraception
- Normal cervical smear
- Smokers not older than 30 years
- History of regular cyclic menstrual periods
Exclusion
- Pregnancy or lactation
- Obesity (BMI\> 30 kg/m2
- Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
- Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- Use of other contraceptive methods than study medication
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
1694 Patients enrolled
Trial Details
Trial ID
NCT00914693
Start Date
April 1 2009
End Date
September 1 2011
Last Update
December 5 2014
Active Locations (66)
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1
Lanús Oeste, Buenos Aires, Argentina, 1824
2
San Isidro, Buenos Aires, Argentina, B1642CLN
3
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1280AEB
4
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425ASQ