Overview

The Effectiveness of Orally Dosed Emergency Contraception in Obese Women study looks at increasing dosage of oral emergency contraceptives in obese women. Obese women have been shown to be significantly more likely to experience failures of emergency contraceptives than women with more normal BMI. The study will focus on emergency contraceptives that contain ulipristal acetate (UPA).

Study Information

The study aims to look at 112 participants and look at the delay in follicular rupture among obese women who take an escalated dose of emergency contraceptives. Women will either be given two doses or one dose of 30mg UPA-based emergency contraceptives and then will receive the opposite dose in their next menstrual cycle. In total, the women will receive 3 doses – the difference is when the doses will be administered.

Inclusion Criteria

• Generally healthy women ages 18-35
• Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
• Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI <25kg/m2 and a weight of less than 80kg.

Exclusion Criteria

• Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
• Impaired liver or renal function
• Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
• Recent (within last 8 weeks) use of hormonal contraception
• Current use of drugs that interfere with metabolism of sex steroids
• Smokers

Locations

OHSU

Portland, Oregon, United States, 97239

Principal Investigator: ALISON EDELMAN, MD, MPH Oregon Health and Science University

Sponsors/Collaborators

Oregon Health and Science University

National Institutes of Health (NIH)