US Ovulation Inhibition Study in Obese Women (NCT00873483) | Clinical Trial Compass
CompletedPhase 2
US Ovulation Inhibition Study in Obese Women
United States173 participantsStarted 2009-04-30
Plain-language summary
Birth Control Patch Study
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.