Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

778 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-12-31

Brief Summary

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The purpose of the study is to evaluate user experience with the EVRAÂ® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRAÂ® Patch, and if applicable, user preference of the EVRAÂ® Patch compared with the previous method of contraception. The study also evaluates contraceptive efficacy, safety and user compliance.

Detailed Description

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EVRA is the first transdermal contraceptive patch to receive approval by Health Canada and Marketing Authorization throughout the European Union. This is an open-label, single-arm, multicenter clinical study with a treatment duration of 24 weeks (6 treatment cycles of 4 weeks). Four clinic visits are scheduled: a screening Visit 1, in which subjects are asked to complete a set of questions about satisfaction with the current method of contraception, and questions about overall health status. Visits 2, 3, and 4 follow after Cycles 1, 3, and 6, respectively of EVRA treatment. At Visits 3 and 4, the subjects are asked to answer questions about satisfaction with EVRA, and about overall health status. At Visit 4 (final study visit) the subjects are asked to compare EVRA with previously used contraceptive methods. Compliance is assessed at all visits by returned boxes of study medication and a review of Diary Cards where subjects recorded the dates and sites of patch application, and details of any patch detachment. The study will generate the first large-scale, European dataset on women's experience with EVRA, including satisfaction, safety, efficacy, and compliance. These data will be compared with subjects' experience with previously used methods of contraception. Each EVRA patch, containing 6 mg NGMN and 600 ug EE, and delivering 150 microgram NGMN and 20 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. Subjects can wear EVRA on 1 of 4 areas: buttock, abdomen, upper torso, or upper arm.

Conditions

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Contraception Female Contraception

Keywords

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contraception female contraception hormonal contraception transdermal contraception EVRA estrogen progestin ethinyl estradiol norelgestromin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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norelgestromin + ethinyl estradiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Regular menstrual cycles
* sexually active and at risk of pregnancy
* nonpregnant
* normal Pap smear

Exclusion Criteria

* Presently have or at risk of venous thrombosis or arterial thrombosis
* migraines with focal aura
* severe hypertension
* diabetes mellitus
* hereditary dyslipoproteinemia
* carcinoma of breast, endometrium or other estrogen-dependent neoplasia
* substance abuse
* skin conditions
* concurrent use of hormone-containing medication
* smoking women over 35 years of age.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

Other Identifiers

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CR002905

Identifier Type: -

Identifier Source: org_study_id