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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307632
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : May 15, 2014
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.

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).

Condition or disease Intervention/treatment Phase
Contraception Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 580 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Study Start Date : February 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

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).

Primary Outcome Measures :
  1. 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.

  2. Pregnancy Rate Determined by Table of Life Analysis [ Time Frame: Cycle 6 (Day 168) ]
    Pregnancy rate was determined by table of life analysis.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307632

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Belo Horizonte, Brazil
Botucatu, Brazil
Brasilia, Brazil
Curitiba, Brazil
Goiânia, Brazil
Porto Alegre, Brazil
Ribeirao Preto, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Ciudad De Mexico, Mexico
Mexico, Mexico
Monterrey, Mexico
Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
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Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial Janssen-Cilag Farmaceutica Ltda.

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Responsible Party: Janssen-Cilag Farmaceutica Ltda. Identifier: NCT00307632     History of Changes
Other Study ID Numbers: CR002962
NRGEEPCON4015 ( Other Identifier: Janssen-Cilag Farmaceutica Ltda. )
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014
Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Hormonal patch
Ethinyl estradiol
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Ethinyl Estradiol
Contraceptive Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female