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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier:
NCT00307632
First received: March 24, 2006
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Contraception
Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Farmaceutica Ltda.:

Primary Outcome Measures:
  • Pregnancy Rate Determined by Pearl Index [ Time Frame: Cycle 6 (Day 168) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Pregnancy rate was determined by table of life analysis.


Secondary Outcome Measures:
  • Percentage of Participants With Breakthrough Bleeding and/or Spotting [ Time Frame: Day 28 of Cycle 1, 3 and 6 ] [ Designated as safety issue: No ]
    Percentage of participants with breakthrough bleeding and/or spotting was reported.

  • Compliance Score [ Time Frame: Day 28 of Cycle 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Response to Satisfaction Questionnaire [ Time Frame: Day 28 of Cycle 1, 3 and 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 580
Study Start Date: February 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307632

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
Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
Investigators
Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial Janssen-Cilag Farmaceutica Ltda.
  More Information

No publications provided

Responsible Party: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT00307632     History of Changes
Other Study ID Numbers: CR002962, NRGEEPCON4015
Study First Received: March 24, 2006
Last Updated: May 14, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Contraception
Hormonal patch
Norelgestromine
Ethinyl estradiol
hormonal patch

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Polyestradiol phosphate
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014