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

Sponsor

Janssen Pharmaceutica N.V., Belgium (Industry)

Overall Status

Completed

CT.gov ID

NCT00261482

Collaborator

(none)

778

Enrollment

17.1

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception Female Contraception	Drug: norelgestromin + ethinyl estradiol	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

778 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label, Multicentre Study of the EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch in Europe: Evaluation of Women's Experience With EVRA� and Comparison With Previously Used Methods of Contraception.

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Level of satisfaction with EVRA after 3 and 6 cycles of use. Comparisons are made between EVRA satisfaction level and that with the previous primary contraceptive method. []

Secondary Outcome Measures

Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study. []