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

May 14, 2014 updated by: Janssen-Cilag Farmaceutica Ltda.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

580

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
      • Botucatu, Brazil
      • Brasilia, Brazil
      • Curitiba, Brazil
      • Goiânia, Brazil
      • Porto Alegre, Brazil
      • Ribeirao Preto, Brazil
      • Sao Paulo, Brazil
      • Sorocaba, Brazil
  • Mexico
      • Ciudad De Mexico, Mexico
      • Mexico, Mexico
      • Monterrey, Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Norelgestromine (NLGM)/Ethinyl Estradiol (EE)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cycle 6 (Day 168)
Pregnancy Rate Determined by Table of Life Analysis
Time Frame: Cycle 6 (Day 168)
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
Time Frame: Day 28 of Cycle 1, 3 and 6
Percentage of participants with breakthrough bleeding and/or spotting was reported.
Day 28 of Cycle 1, 3 and 6
Compliance Score
Time Frame: Day 28 of Cycle 1, 2, 3, 4, 5 and 6
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
Time Frame: Day 28 of Cycle 1, 3 and 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Farmaceutica Ltda.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

March 24, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002962
  • NRGEEPCON4015 (Other Identifier: Janssen-Cilag Farmaceutica Ltda.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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