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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00307632

NRGEEPCON4015 (Other Identifier)

CR002962

Details and patient eligibility

About

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).

Full 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.

Enrollment: 580 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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580 participants in 1 patient group

Norelgestromine (NLGM)/Ethinyl Estradiol (EE)

Experimental group

Treatment:

Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)