Overview
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Status:
Recruiting
Recruiting
Trial end date:
2021-10-01
2021-10-01
Target enrollment:
0
0
Participant gender:
Female
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 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Oregon Health and Science UniversityCollaborator:
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.