An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Information source: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Norelgestromine (NLGM)/ethinyl estradiol (EE) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen-Cilag Farmaceutica Ltda. Official(s) and/or principal investigator(s): Janssen-Cilag Farmaceutica Ltda. Clinical Trial, Study Director, Affiliation: Janssen-Cilag Farmaceutica Ltda.
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).
Clinical Details
Official title: An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Pregnancy Rate Determined by Pearl IndexPregnancy Rate Determined by Table of Life Analysis
Secondary outcome: Percentage of Participants With Breakthrough Bleeding and/or SpottingCompliance Score Percentage of Participants With Response to Satisfaction Questionnaire
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
Minimum age: 21 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
Belo Horizonte, Brazil
Botucatu, Brazil
Brasilia, Brazil
Curitiba, Brazil
GoiĆ¢nia, Brazil
Porto Alegre, Brazil
Ribeirao Preto, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Ciudad De Mexico, Mexico
Mexico, Mexico
Monterrey, Mexico
Additional Information
Starting date: February 2003
Last updated: May 14, 2014
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