A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-label Study to Evaluate the Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17-deacetylnorgestimate and Ethinyl Estradiol With the Oral Contraceptive Triphasil.

The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Triphasil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multicenter, worldwide study to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal patch compared with Triphasil. Fourteen hundred healthy women will receive study medication for either 6 or 13 cycles. The first 33% of subjects (~265 transdermal patch subjects and 200 Triphasil subjects) will be expected to complete 13 cycles of medication. All subsequent subjects will be expected to complete 6 cycles. The ratio of subjects assigned to the transdermal patch arm of the study and to the Triphasil arm will be 4:3. At admission (Visit 1) study drug (plus 3 reserve patches), diary cards and subject instructions for Cycle 1 are dispensed. The first patch will be applied and Triphasil pill will be taken on the first day of menses. Study medication and diary cards will be issued on day 28 of Cycles 1 (Visit 2) and 3 (Visit 3), and those continuing for 13 cycles will receive study drug again (plus 3 reserve patches) on day 28 of Cycles 6 (Visit 4) and 9 (Visit 5). Diary cards and empty medication packages will be collected at every visit. Final visits are on day 28 of Cycles 6 and 9. Diary card information is used to record compliance and bleeding information (to assess cycle control). Contraceptive efficacy was assessed by means of the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety evaluations were based on adverse events, which were collected throughout the study, and changes in physical examinations, gynecologic examinations, vital signs, and laboratory results from prestudy to final visit. A transdermal patch, containing 6 mg NGM and 0.75 mg EE, delivering 250 ug NGM and 25 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks.The fourth week is patch-free. A Triphasil pill is taken for 28 consecutive days at the same time each day.

Study Type

Interventional

Enrollment (Actual)

1494

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy, nonpregnant women with regular menstrual cycles
  • sexually active and at risk of pregnancy
  • acceptable body mass index (BMI)
  • last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since
  • sitting BP<140mmHg/<90mmHg
  • 1 normal menstrual cycle since removal of IUD or norplant
  • agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment
  • agree not to use other systemic steroid medication

Exclusion Criteria:

  • Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders
  • cerebral vascular or coronary artery disease, hypertension, or severe migraines
  • liver tumor resulting from estrogen-containing products
  • diabetes mellitus
  • cholestatic jaundice, liver or renal disease
  • abnormal PAP smear
  • undiagnosed abnormal vaginal bleeding
  • thyroid disorder
  • dermal hypersensitivity
  • carcinoma of breast, genital tract or other estrogen-dependent neoplasia
  • received any depot hormone injection within prior 6 months
  • smoking women over 35 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.

Secondary Outcome Measures

Outcome Measure
Cycle control and compliance were assessed with diary cards containing bleeding and dosing information.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Study Completion (ACTUAL)

March 1, 1999

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (ESTIMATE)

October 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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