NCT00307632

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
580

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2003

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

March 24, 2006

Last Update Submit

May 14, 2014

Conditions

Contraception

Keywords

ContraceptionHormonal patchNorelgestromineEthinyl estradiol

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Pregnancy Rate Determined by Table of Life Analysis

    Pregnancy rate was determined by table of life analysis.

    Cycle 6 (Day 168)

Secondary Outcomes (3)

  • Percentage of Participants With Breakthrough Bleeding and/or Spotting

    Day 28 of Cycle 1, 3 and 6

  • Compliance Score

    Day 28 of Cycle 1, 2, 3, 4, 5 and 6

  • Percentage of Participants With Response to Satisfaction Questionnaire

    Day 28 of Cycle 1, 3 and 6

Study Arms (1)

Norelgestromine (NLGM)/Ethinyl Estradiol (EE)

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

Interventions

Norelgestromine (NLGM)/ethinyl estradiol (EE)DRUG

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).

Norelgestromine (NLGM)/Ethinyl Estradiol (EE)

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Botucatu, Brazil

Location

Unknown Facility

Brasília, Brazil

Location

Unknown Facility

Curitiba, Brazil

Location

Unknown Facility

Goiânia, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Ribeirão Preto, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Sorocaba, Brazil

Location

Unknown Facility

Mexico City, Mexico

Location

Unknown Facility

México, Mexico

Location

Unknown Facility

Monterrey, Mexico

Location

Study Officials

  • Janssen-Cilag Farmaceutica Ltda. Clinical Trial

    Janssen-Cilag Farmaceutica Ltda.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

February 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations

BR(9)ME(3)