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Status
Completed
Phase
I
Objective
Phase I, 90-Day Safety, Pharmacokinetic, And Pharmacodynamic Study Of Intravaginal Rings Releasing Tenofovir And Levonorgestrel
Prevention Option(s)
Microbicides
Multipurpose Prevention Technologies
Study Design
Randomized
Arms and Assigned Interventions
Description
TFV/LNG IVR
Used for 90 days (Continuous or Interrupted)
Mode of Delivery
Ring
Products
Levonorgestrel
tenofovir
ARMs
Experimental
Description
TFV/LNG IVR
Used for 90 days (Continuous or Interrupted)
Mode of Delivery
Ring
Products
Levonorgestrel
tenofovir
ARMs
Experimental
Description
Used for 90 days (Continuous or Interrupted)
Mode of Delivery
Ring
ARMs
Placebo Comparator
Description
Used for 90 days (Continuous or Interrupted)
Mode of Delivery
Ring
ARMs
Placebo Comparator
Official Code
September 2017
December 2018
Enrollment
66
18
Years
50
Population
Men
Sites
Eastern Virginia Medical School
Norfolk, Virginia
United States of America
Profamilia
Santo Domingo
Dominican Republic