Emergency Contraception and Body Weight: Pilot Study

Contraception Clinical Trial

Official title: Emergency Contraception and Body Weight: Pilot Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Body Weight
• Contraception
• Emergencies

• NCT number: NCT02408692
• Study type: Interventional
• Source: Oregon Health and Science University
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Completion date: August 2015