US Ovulation Inhibition Study in Obese Women

Completed · Phase 2

Conditions studied: Contraception

In brief

Birth Control Patch Study

Key facts

Study ID: NCT00873483
Run by: Bayer
People needed: 173
Starts: 2009-04-30
Expected to finish: 2010-03-03
Last updated by the study team: 2021-04-08

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Study site — Tucson, Arizona, United States
Study site — San Diego, California, United States
Study site — Sandy Springs, Georgia, United States
Study site — Philadelphia, Pennsylvania, United States
Study site — Houston, Texas, United States
Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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