Pericoital Oral Contraception With Levonorgestrel

Healthy Clinical Trial

Official title: Pericoital Oral Contraception With Levonorgestrel: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Acceptability

Status Completed

Clinical Trial Summary

A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel

Clinical Trial Description

This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study as stated in the study protocol are as follows:

• To evaluate the efficacy of the study regimen among women who have sex 1-4 days a month and who are relying on the study regimen as their primary method of contraception

• To evaluate the safety of this regimen, with particular emphasis on its effects on vaginal bleeding patterns and anemia

• To evaluate the acceptability of the regimen The study will enroll fertile women of reproductive age who have sex up to 6 days a month, are at low risk for sexually transmitted infections (STIs), have no contraindications to progestin-only oral contraceptives,have no serious contraindications to pregnancy, and are willing to use an investigational method of contraception as their only contraceptive method for 6.5 months (each tablet contains 0.75 mg LNG to be used after every sex act). ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT00922233
• Study type: Interventional
• Source: FHI 360
• Status: Completed
• Phase: Phase 3
• Start date: January 2010
• Completion date: November 2010