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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307632
• Other study ID #: CR002962
• Secondary ID: NRGEEPCON4015
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2006
• Last updated: May 14, 2014
• Start date: February 2003
• Est. completion date: December 2004

Study information

• Verified date: May 2014
• Source: Janssen-Cilag Farmaceutica Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Farmaceutica Ltda.

Countries where clinical trial is conducted

Brazil,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate Determined by Pearl Index	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.	Cycle 6 (Day 168)	No
Primary	Pregnancy Rate Determined by Table of Life Analysis	Pregnancy rate was determined by table of life analysis.	Cycle 6 (Day 168)	No
Secondary	Percentage of Participants With Breakthrough Bleeding and/or Spotting	Percentage of participants with breakthrough bleeding and/or spotting was reported.	Day 28 of Cycle 1, 3 and 6	No
Secondary	Compliance Score	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.	Day 28 of Cycle 1, 2, 3, 4, 5 and 6	No
Secondary	Percentage of Participants With Response to Satisfaction Questionnaire	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.	Day 28 of Cycle 1, 3 and 6	No