Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

• Status: Active, not 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. The PI's 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. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG 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: Levonorgestrel

Criteria

Inclusion Criteria:

• Generally health women

• Aged 18-35 years old

• Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3ng/ml or greater.

• Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.

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.