IPM 035
Status:Completed
Phase:I
Principal Investigator(s):
Objective:IPM 035 is a clinical trial designed to assess the effects of menses, and of tampon use during menses, on the local and systemic pharmacokinetics of the dapivirine ring when used by HIV-negative women over a period of 28 days.
*In data analysis as of August 2016*
Last updated May 15, 2021
Prevention Option(s):Microbicides
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionIn Cohort I, eligible participants will be randomly assigned to one of two treatment sequences (ABE or BAE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence
Mode of DeliveryRing
ARMsExperimental
DescriptionIn Cohort II, eligible participants will be randomly assigned to one of two treatment sequences (CDE or DCE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence
Mode of DeliveryRing
ARMsExperimental
Official Code:
NCT02858024
Trial Sponsors:
IPM
Start Date
End Date
January 12, 2015
April 16, 2016
Enrollment:16
Age range:
18 Years ↔
45 Years
Population:Cisgender Women