drugset / Trial / 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)

NCT02616146

Phase 3 Terminated 2016 enrolled Organon and Co
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2015-12-01
Primary completion
2016-10-06
Completion
2016-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 300 ug Other
Subject Etonogestrel Unknown 125 ug Other
Comparator Levonorgestrel Small molecule 150 ug Oral
Comparator ethinyl estradiol Small molecule 30 ug Oral

Indications

No indication recorded.