NCT00236782

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,517 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is an open-label, multicenter, international study to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal patch compared with Mercilon. Fourteen hundred healthy women will receive study medication for either 6 or 13 cycles. The first 265 transdermal patch subjects and the first 200 Mercilon subjects will be expected to complete 13 cycles of medication. All subsequent subjects will be expected to complete 6 cycles. The ratio of subjects assigned to the transdermal patch arm of the study and to the Mercilon arm will be 4:3. At admission (Visit 1) study drug, diary cards and subject instructions for Cycle 1 and replacement patches for Cycles 1 to 6 are dispensed. The first patch will be applied and Mercilon pill will be taken on the first day of menses. Study medication and diary cards will be issued on day 28 of Cycles 1 (Visit 2) and 3 (Visit 3), and those continuing for 13 cycles will receive study drug again on day 28 of Cycles 6 (Visit 4) and 9 (Visit 5). Diary cards and empty medication packages will be collected at every visit. Final visits are on day 28 of Cycles 6 and 9. Diary card information was used to record compliance and bleeding information (to assess cycle control). Contraceptive efficacy was assessed by means of the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety evaluations were based on adverse events, which were collected throughout the study, and changes in gynecologic examinations, vital signs, and laboratory results from prestudy to final visit. A transdermal patch, containing 6 mg NGM and 0.75 mg EE, delivering 250 ug NGM and 25 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks.The fourth week is patch-free. A Mercilon pill is taken for 21 consecutive days followed by a 7-day pill-free week.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	norelgestromin + ethinyl estradiol; mercilon

Timeline

• Start date: 1997-10-01
• Completion: 1999-03-01
• First posted: 2005-10-12
• Last updated: 2011-06-08