Status:
COMPLETED
Birth Control Patch Study
Lead Sponsor:
Bayer
Collaborating Sponsors:
Parexel
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of t...
Eligibility Criteria
Inclusion
- Healthy women requesting contraception aged 18-35 years old
- Smokers must not be older than 30 at time of informed consent
- History of regular cyclic menstrual periods, normal cervical smear
Exclusion
- Pregnancy or lactation
- Obesity (BMI\>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
393 Patients enrolled
Trial Details
Trial ID
NCT00984789
Start Date
May 1 2009
End Date
September 1 2010
Last Update
April 2 2014
Active Locations (23)
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1
Mödling, Lower Austria, Austria, 2340
2
Wiener Neustadt, Lower Austria, Austria, 2700
3
Graz, Styria, Austria, 8036
4
Wörgl, Tyrol, Austria, 6300