NCT02616146

Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)

A Phase 3, Randomized, Active-Comparator Controlled Clinical Trial to Study the Contraceptive Efficacy and Safety of the MK-8342B (Etonogestrel + 17β-Estradiol) Vaginal Ring and the Levonorgestrel-Ethinyl Estradiol (LNG-EE) 150/30 μg Combined Oral Contraceptive (COC) in Healthy Women 18 Years of Age and Older, at Risk for Pregnancy.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,016 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the contraceptive efficacy of the etonogestrel + 17β-estradiol (ENG-E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150/30 μg combined oral contraceptive (COC) will be used as the active comparator.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	ENG-E2 125 μg/300 μg vaginal ring	Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
DRUG	LNG-EE 150 μg/30 μg COC	Up to 13 cycles of LNG-EE 150 μg/30 μg administered orally, each cycle consisting of one tablet per day for 21 days, followed a 7-day tablet-free interval.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-10-06
• Completion: 2016-10-06
• First posted: 2015-11-26
• Last updated: 2024-05-17
• Results posted: 2019-01-18

Locations

14 sites across 14 countries: Austria, Costa Rica, Denmark, Finland, Germany, Hungary, Italy, Mexico, Netherlands, Norway, Peru, Poland, South Africa, Sweden