NCT01755741

Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

A Multicenter, Open-Label, Randomized, Two-Period, Crossover Non-inferiority Trial to Assess the Functionality of Male Condoms With a Silicone Elastomer Vaginal Ring

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the vaginal ring.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Placebo Vaginal Ring	a silicone elastomer placebo vaginal ring, similar in composition to the dapivirine Ring-004 (which is currently used in IPM's ongoing Phase III program), except that it did not contain any active pharmaceutical agent, and a commercially available standard male latex condom with a silicone-based lubricant.
DEVICE	Condom	Male condom

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-12-24
• Last updated: 2018-03-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study