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.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: norelgestromine and ethinyl estradiol (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: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome is efficacy during the treatment period of 6 weeks.
Secondary outcome: The other outcomes are safety, cycle control, compliance and subject satisfaction during the treatment period of 6 weeks.
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
- Aceptable 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, antiepleptics, 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
Additional Information
Starting date: April 2003
Ending date: December 2004
Last updated: October 19, 2007
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