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Evaluation of Women's Experience With EVRA® (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
This study has been completed.
Study NCT00261482   Information provided by Janssen Pharmaceutica N.V., Belgium
First Received: December 2, 2005   Last Updated: October 19, 2007   History of Changes

December 2, 2005
October 19, 2007
July 2003
 
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.
Same as current
Complete list of historical versions of study NCT00261482 on ClinicalTrials.gov Archive Site
Efficacy is determined using the Pearl Index and the life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
Same as current
 
Evaluation of Women's Experience With EVRA® (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
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.

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.

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.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Contraception
  • Female Contraception
Drug: norelgestromin + ethinyl estradiol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1000
December 2004
 

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00261482
 
CR002905
Janssen Pharmaceutica N.V., Belgium
 
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V., Belgium
Janssen Pharmaceutica N.V., Belgium
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP