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

NCT00307632 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2014-05-15

No results posted yet for this study

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).

Conditions

  • Contraception

Interventions

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).

Sponsors & Collaborators

  • Janssen-Cilag Farmaceutica Ltda.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Farmaceutica Ltda. Clinical Trial · Janssen-Cilag Farmaceutica Ltda.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • Brazil
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00307632 on ClinicalTrials.gov