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drugset / Trial / NCT01277640

Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

NCT01277640 ↗

Phase 1 Completed 48 enrolled International Partnership for Microbicides, Inc.

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.

Timeline

Start: 2011-03
Primary completion: 2011-07
Completion: 2011-07

Publications

Results Cranston RD, Hoesley C, Carballo-Dieguez A, Hendrix CW, Husnik M, Levy L, Hall W, Soto-Torres L, Nel AM. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). AIDS Res Hum Retroviruses. 2014 Feb;30(2):184-9. doi: 10.1089/AID.2013.0170. Epub 2013 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	dapivirine	Small molecule	2.5 g	Topical

Indications

No indication recorded.