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Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

NCT01277640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-09-08

No results posted yet for this study

Summary

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

Conditions

  • Topical Penile Exposures

Interventions

DRUG

dapivirine

* dosage form: gel 0.05% * dosage: 2.5g * frequency: once daily * duration: 7 days

DRUG

matched placebo

* dosage form: gel, no api * dosage: 2.5g * frequency: once daily * duration: 7 days

DRUG

universal placebo

* dosage form: gel, HEC-based * dosage: 2.5g * frequency: once daily * duration: 7 days

Sponsors & Collaborators

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Ross D. Cranston, MD, FRCP · Division of Infectious Diseases, University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277640 on ClinicalTrials.gov