Overview

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.