Overview
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
Status:
Completed
Completed
Trial end date:
2004-12-01
2004-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Janssen Pharmaceutica N.V., BelgiumTreatments:
Contraceptive Agents
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Norelgestromin
Norgestrel
Polyestradiol phosphate
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.