MTN 036 / IPM 047
Status:Completed
Phase:I
Principal Investigator(s):
Objective:MTN-036/IPM 047 is a Phase 1, randomized, three-arm, open label trial. The study will assess the safety and pharmacokinetics (PK) of three silicone elastomer intravaginal rings (VRs) containing either 25 mg or 200 mg of the active ingredient dapivirine (DPV) formulated using either polymer 4320 or 4870.
*The study is closed to follow up*
Last updated May 9, 2021
Prevention Option(s):Microbicides
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionParticipants will insert one Dapivirine Vaginal Ring, 25 mg to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks.
Mode of DeliveryRing
ARMsExperimental
DescriptionParticipants will insert one Dapivirine Vaginal Ring, 100 mg to be used continuously for 13 weeks
Mode of DeliveryRing
ARMsExperimental
DescriptionParticipants will insert one Dapivirine Vaginal Ring, 200 mg to be used continuously for 13 weeks.
Mode of DeliveryRing
ARMsExperimental
Official Code:
NCT03234400
Trial Sponsors:
IPM, NIAID, NICHD, NIH, NIMH
Start Date
End Date
December 4, 2017
January 23, 2019
Enrollment:49
Age range:
18 Years ↔
45 Years
Population:Cisgender Women