A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.

• Status: Completed
• Trial end date: 1999-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Triphasil.

• Phase: Phase 3
• 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; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination; Norelgestromin; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Healthy, nonpregnant women with regular menstrual cycles

• sexually active and at risk of pregnancy

• acceptable body mass index (BMI)

• last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since

• sitting BP<140mmHg/<90mmHg

• 1 normal menstrual cycle since removal of IUD or norplant

• agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment

• agree not to use other systemic steroid medication

Exclusion Criteria:

• Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders

• cerebral vascular or coronary artery disease, hypertension, or severe migraines

• liver tumor resulting from estrogen-containing products

• diabetes mellitus

• cholestatic jaundice, liver or renal disease

• abnormal PAP smear

• undiagnosed abnormal vaginal bleeding

• thyroid disorder

• dermal hypersensitivity

• carcinoma of breast, genital tract or other estrogen-dependent neoplasia

• received any depot hormone injection within prior 6 months

• smoking women over 35 years of age.