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

Sponsor

Janssen-Cilag Farmaceutica Ltda. (Industry)

Overall Status

Completed

CT.gov ID

NCT00307632

Collaborator

(none)

580

Enrollment

Locations

Arm

Duration (Months)

48.3

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE)	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

580 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Norelgestromine (NLGM)/Ethinyl Estradiol (EE)	Drug: Norelgestromine (NLGM)/ethinyl estradiol (EE) Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).

Arm

Intervention/Treatment

Experimental: Norelgestromine (NLGM)/Ethinyl Estradiol (EE)

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

Participants will apply a 20 centimeter square (cm^2) contraceptive transdermal patch on the skin for 1 full week, and then apply a fresh patch for Week 2, and a third patch for Week 3. The fourth week will be patch-free. Each patch delivers 150 microgram (mcg) of NLGM and 20 mcg of EE per day. The treatment duration is of 6 cycles (4 weeks each).

Outcome Measures

Primary Outcome Measures

Pregnancy Rate Determined by Pearl Index [Cycle 6 (Day 168)]
Pearl Index is the number of pregnancies with use of therapy divided by the number of cycles with therapy use. It is an estimation of the number of pregnancies per 100 woman-years of product use.
Pregnancy Rate Determined by Table of Life Analysis [Cycle 6 (Day 168)]
Pregnancy rate was determined by table of life analysis.

Secondary Outcome Measures

Percentage of Participants With Breakthrough Bleeding and/or Spotting [Day 28 of Cycle 1, 3 and 6]
Percentage of participants with breakthrough bleeding and/or spotting was reported.
Compliance Score [Day 28 of Cycle 1, 2, 3, 4, 5 and 6]
Score of compliance was calculated for each participant by dividing the number of cycles with at least one day without the study drug by the total number of therapy cycles. Average score was calculated for cycle 1 to 6.
Percentage of Participants With Response to Satisfaction Questionnaire [Day 28 of Cycle 1, 3 and 6]
Percentage of participants with response to satisfaction questionnaire was reported for following categories: previous contraceptive, method election, physical well-being, emotional well-being, intermenstrual bleeding and intensity, menstrual flow volume, pre-menstrual symptoms, and easiness in ethinyl estradiol and norelgestromin transdermal patch use.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	City	Country
1	Belo Horizonte	Brazil
2	Botucatu	Brazil
3	Brasilia	Brazil
4	Curitiba	Brazil
5	Goiânia	Brazil
6	Porto Alegre	Brazil
7	Ribeirao Preto	Brazil
8	Sao Paulo	Brazil
9	Sorocaba	Brazil
10	Ciudad De Mexico	Mexico
11	Mexico	Mexico
12	Monterrey	Mexico