An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Overview
- Phase
- Phase 4
- Intervention
- Norelgestromine (NLGM)/ethinyl estradiol (EE)
- Conditions
- Contraception
- Sponsor
- Janssen-Cilag Farmaceutica Ltda.
- Enrollment
- 580
- Primary Endpoint
- Pregnancy Rate Determined by Pearl Index
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult females who meet the following selection criteria: Have regular menses occuring every 25-35 days
- •Acceptable body mass (\< 30) and the weight is \< 90 kg
- •Has completed her last term pregnancy at least 4 months prior to study admission, is not lactating and has at least one normal menstrual period since her last pregnancy and not breast feeding
- •Has a sitting blood pressure systolic \< 140 mm/Hg and diastolic \< 90 mm/Hg.
Exclusion Criteria
- •Has not received a DepoProvera injection or any other depot hormone injection within six months prior to the screening visit
- •Has not used / or in current use of barbiturates, antiepileptics, rifampin, griseofulvin, Hypericum perforatum, or other hepatic enzyme-inducing drugs within 30 days prior to the pre-study visit
- •Has not a uncontrolled disorder
- •No women over the age 35 who smoke.
Arms & Interventions
Norelgestromine (NLGM)/Ethinyl Estradiol (EE)
Intervention: Norelgestromine (NLGM)/ethinyl estradiol (EE)
Outcomes
Primary Outcomes
Pregnancy Rate Determined by Pearl Index
Time Frame: Cycle 6 (Day 168)
Pearl Index is the number of pregnancies with use of therapy divided by the number of cycles with therapy use. It is an estimation of the number of pregnancies per 100 woman-years of product use.
Pregnancy Rate Determined by Table of Life Analysis
Time Frame: Cycle 6 (Day 168)
Pregnancy rate was determined by table of life analysis.
Secondary Outcomes
- Percentage of Participants With Breakthrough Bleeding and/or Spotting(Day 28 of Cycle 1, 3 and 6)
- Compliance Score(Day 28 of Cycle 1, 2, 3, 4, 5 and 6)
- Percentage of Participants With Response to Satisfaction Questionnaire(Day 28 of Cycle 1, 3 and 6)