Overview

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.