An Open-label Study to Evaluate the Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17-deacetylnorgestimate and Ethinyl Estradiol With the Oral Contraceptive Triphasil.

NCT00236795 Phase 3 COMPLETED

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

Details

Lead sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase	Phase 3
Status	COMPLETED
Enrolment	1494
Start date	1997-01
Completion	1999-03

Conditions

• Contraception
• Female Contraception

Interventions

• norelgestromin + ethinyl estradiol; triphasil.

Primary outcomes

• Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.