Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: National Institutes of Health (NIH)
• Treatments: Ulipristal acetate

Criteria

Inclusion Criteria:

• Generally healthy women

• Aged 18-35 years old

• 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.