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

Contraception Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261482
• Other study ID #: CR002905
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2005
• Last updated: November 15, 2010
• Start date: July 2003
• Est. completion date: December 2004

Study information

• Verified date: November 2010
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 778
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Contraception
• Female Contraception

Intervention

Drug:
• norelgestromin + ethinyl estradiol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.