drugset / Trial / NCT01306331

Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel

NCT01306331

Phase 3 Completed 3389 enrolled Evofem Inc. Premier Research · collab
RandomizedParallel-groupOpen-labelPrevention

Summary

This is a research study of a new experimental vaginal gel that helps in vaginal pH regulation and results in immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously known as Amphora) and was compared to a commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study objective was to determine if this product prevents pregnancy when inserted into the vagina before intercourse.

Timeline

Start
2011-04
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject AMPHORA Unknown 5 ml Other
Comparator Nonoxynol-9 Small molecule 100 mg Other

Indications

No indication recorded.