Status:
COMPLETED
An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Lead Sponsor:
Janssen-Cilag Farmaceutica Ltda.
Conditions:
Contraception
Eligibility:
FEMALE
21-45 years
Phase:
PHASE4
Brief 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 es...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00307632
Start Date
February 1 2003
End Date
December 1 2004
Last Update
May 15 2014
Active Locations (12)
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1
Belo Horizonte, Brazil
2
Botucatu, Brazil
3
Brasília, Brazil
4
Curitiba, Brazil