Bioequivalence Study of Patches With Different Equilibration Profiles

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this single center, randomized, double-blind, 2 way crossover study was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Contraceptive Agents; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Norelgestromin; Norgestrel; Ortho Evra; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Healthy as determined by physical and gynecologic examinations, clinical laboratory assessments, vital sign measurements, and a 12-lead electrocardiogram (ECG)

Exclusion Criteria:

• Pregnant

• Lactating

• Currently using hormonal contraceptive