Status:
COMPLETED
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Contraception
Female Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 th...
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 clinica...
Eligibility Criteria
Inclusion
- Regular menstrual cycles
- sexually active and at risk of pregnancy
- nonpregnant
- normal Pap smear
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
778 Patients enrolled
Trial Details
Trial ID
NCT00261482
Start Date
July 1 2003
End Date
December 1 2004
Last Update
November 16 2010
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