NCT02408692

Emergency Contraception and Body Weight: Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations. We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.

Conditions

• Contraception
• Body Weight

Interventions

Type	Name	Description
DRUG	ECx1	At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
DRUG	ECx2	At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-04-03
• Last updated: 2017-10-25
• Results posted: 2017-06-02

Locations

1 site across 1 country: United States