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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norelgestromine (NLGM)/Ethinyl Estradiol (EE)<br> | Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate Determined by Pearl Index | 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. | Cycle 6 (Day 168) | 
| Pregnancy Rate Determined by Table of Life Analysis | Pregnancy rate was determined by table of life analysis. | Cycle 6 (Day 168) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Breakthrough Bleeding and/or Spotting | Percentage of participants with breakthrough bleeding and/or spotting was reported. | Day 28 of Cycle 1, 3 and 6 | 
| Compliance Score | Score of compliance was calculated for each participant by dividing the number of cycles with at least one day without the study drug by the total number of therapy cycles. Average score was calculated for cycle 1 to 6. | Day 28 of Cycle 1, 2, 3, 4, 5 and 6 | 
| Percentage of Participants With Response to Satisfaction Questionnaire | Percentage of participants with response to satisfaction questionnaire was reported for following categories: previous contraceptive, method election, physical well-being, emotional well-being, intermenstrual bleeding and intensity, menstrual flow volume, pre-menstrual symptoms, and easiness in ethinyl estradiol and norelgestromin transdermal patch use. | Day 28 of Cycle 1, 3 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Hormonal patch, Norelgestromine, Ethinyl estradiol