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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261482
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : November 16, 2010
Information provided by:
Janssen Pharmaceutica N.V., Belgium

Brief 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.

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 Type : Interventional  (Clinical Trial)
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 : July 2003
Actual Study Completion Date : December 2004

Primary Outcome Measures :
  1. 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 :
  1. Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00261482

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V. Identifier: NCT00261482     History of Changes
Other Study ID Numbers: CR002905
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
female contraception
hormonal contraception
transdermal contraception
ethinyl estradiol

Additional relevant MeSH terms:
Contraceptive Agents, Female
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptives, Oral, Synthetic