Overview

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

Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Treatments:
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.