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

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00261482
First received: December 2, 2005
Last updated: November 15, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Contraception
Female Contraception
Drug: norelgestromin + ethinyl estradiol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

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.

Enrollment: 778
Study Start Date: July 2003
Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261482

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00261482     History of Changes
Other Study ID Numbers: CR002905
Study First Received: December 2, 2005
Last Updated: November 15, 2010
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

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

ClinicalTrials.gov processed this record on October 23, 2014