Status:
COMPLETED
US Ovulation Inhibition Study in Obese Women
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
Birth Control Patch Study
Eligibility Criteria
Inclusion
- Female subject requesting contraception
- Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- History of regular cyclic menstrual periods
- Willingness to use non-hormonal methods of contraception during the entire study.
Exclusion
- Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drug
- Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
- Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
- Any disease or condition that may worsen under hormonal treatment.
Key Trial Info
Start Date :
April 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2010
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00873483
Start Date
April 30 2009
End Date
March 3 2010
Last Update
April 8 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Tucson, Arizona, United States, 85712
2
San Diego, California, United States, 92108
3
Sandy Springs, Georgia, United States, 30328
4
Philadelphia, Pennsylvania, United States, 19114