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CONRAD A15-138

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
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