NCT00307632

An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: Janssen-Cilag Farmaceutica Ltda. · Industry
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal contraceptive system, norelgestromine and ethinyl estradiol (NLGM / EE).

Detailed description

A multicenter, open label, descriptive study. Five hundred requiring contraception will receive the weekly transdermal contraceptive patch for 6 cycles. At the baseline and after the 1st, 3rd and 6th cycles, satisfaction with the method will be assessed. The contraceptive efficacy will be assessed by the Pearl Index and by life table analysis. To assess satisfaction with the weekly transdermal contraceptive patch, this method will be compared to the previous contraceptive method. Adhesion, cycle control, safety and efficacy are secondary outcomes. Treatment duration: 6 cycles (4 weeks each). The subject will wear a 20 cm2 contraceptive transdermal patch for one full week, apply a fresh patch for week 2, and a third patch for week 3. The fourth week will be patch-free. Each patch deliveries 150 mcg of NLGM and 20 mcg of EE per day.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Norelgestromine (NLGM)/ethinyl estradiol (EE)	Participants will apply a 20 centimeter square (cm\^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2006-03-28
• Last updated: 2014-05-15

Locations

12 sites across 2 countries: Brazil, Mexico