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:
Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier:
NCT00307632
First received: March 24, 2006
Last updated: November 29, 2010
Last verified: November 2010
  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 and ethinyl estradiol
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:
  • The primary outcome is efficacy during the treatment period of 6 weeks.

Secondary Outcome Measures:
  • The other outcomes are safety, cycle control, compliance and subject satisfaction during the treatment period of 6 weeks.

Enrollment: 580
Study Start Date: April 2003
Study Completion Date: December 2004
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307632

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

ClinicalTrials.gov Identifier: NCT00307632     History of Changes
Other Study ID Numbers: CR002962
Study First Received: March 24, 2006
Last Updated: November 29, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Contraception
hormonal patch

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

ClinicalTrials.gov processed this record on April 17, 2014