Emergency Contraception and Body Weight: Pilot Study

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.

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

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Medical Research Foundation, Oregon
• Treatments: Levonorgestrel

Criteria

Inclusion Criteria:

• Subjects are between the ages of 18 and 35

• Subjects are in good general health

• Subjects have regular menstrual cycles (between 21 and 35 days)

• Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).

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 (8 week) use of hormonal contraception

• Current use of drugs that interfere with metabolism of sex steroids

• Smokers.