Clinical trial NCT00307632: An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Official title: An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Contraception
Hormonal patch
Norelgestromine
Ethinyl estradiol
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2006-03-28
Enrollment: 580
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 estradiol (NLGM / EE).

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 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.

Primary outcomes:
measure: Pregnancy Rate Determined by Pearl Index
timeFrame: Cycle 6 (Day 168)
measure: Pregnancy Rate Determined by Table of Life Analysis
timeFrame: Cycle 6 (Day 168)
Secondary outcomes:
measure: Percentage of Participants With Breakthrough Bleeding and/or Spotting
timeFrame: Day 28 of Cycle 1, 3 and 6
measure: Compliance Score
timeFrame: Day 28 of Cycle 1, 2, 3, 4, 5 and 6
measure: Percentage of Participants With Response to Satisfaction Questionnaire
timeFrame: Day 28 of Cycle 1, 3 and 6
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
city: Botucatu
country: Brazil
city: Brasilia
country: Brazil
city: Curitiba
country: Brazil
city: Goiânia
country: Brazil
city: Porto Alegre
country: Brazil
city: Ribeirao Preto
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Ciudad De Mexico
country: Mexico
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
Study officials:
affiliation: Janssen-Cilag Farmaceutica Ltda.
name: Janssen-Cilag Farmaceutica Ltda. Clinical Trial
role: STUDY_DIRECTOR
References: