MTN-044/IPM 053/ CCN019

Status:Completed
Phase:Open Label, I
Principal Investigator(s):
Objective:This is a Phase I single-center, two-arm, open-label, randomized study in healthy HIV-negative women to evaluate the pharmacokinetics, safety, and bleeding patterns associated with 90-day use of matrix vaginal rings containing 200 mg Dapivirine and 320 mg Levonorgestrel.One silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used continuously for approximately 90 days.   Last updated May 3, 2021
Prevention Option(s):Microbicides, MPTs
Study Design:Randomized
Arms and Assigned Interventions
DescriptionOne silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used continuously for approximately 90 days.
Mode of DeliveryRing
ARMsExperimental
DescriptionOne silicone elastomer vaginal ring (VR) containing the active 200 mg dapivirine (DPV) and 320 mg levonorgestrel (LNG), used cyclically for approximately 90 days. Use the VR for 28 days, remove for 2 days.
Mode of DeliveryRing
ARMsExperimental
Official Code: NCT03467347
Start Date
End Date
July 17, 2018
October 7, 2019
Enrollment:25
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women