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IPM 036

Status
Completed
Phase
I
Objective

IPM 036 is an open-label, randomized, crossover Phase I clinical trial designed to assess the potential drug-drug interactions as well as the safety of co-administration of the dapivirine ring and vaginally administered clotrimazole, a drug commonly used to treat vaginal infections.

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Dapivirine Ring-004 for 28 days
Products
Dapivirine Ring
ARMs
Experimental
Description
Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days
Products
Dapivirine Ring
ARMs
Experimental
Description
Clotrimazole, 5 g per day for 7 days
ARMs
Experimental
Trial Sponsors
IPM
September 2015
April 2017
Enrollment
36
18
Years
45
Years
Population
Women
Sites

SGS Life Sciences

Belgium