A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04

Status:Completed
Phase:I
Principal Investigator(s):Katherine Bunge, Sharon Hillier
Objective:This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial assessing the safety of tenofovir vaginal gel and film formulations.   Last updated May 15, 2021
Prevention Option(s):Microbicides, MPTs
Study Design:Randomized
Arms and Assigned Interventions
Description1% vaginally applied tenofovir gel administered for 7 daily doses
Mode of DeliveryGel
ARMsExperimental
DescriptionHEC placebo vaginal gel administered for 7 daily doses
Mode of DeliveryGel
ARMsPlacebo Comparator
DescriptionTenofovir Film 10mg inserted vaginally, administered for 7 daily doses
Mode of DeliveryFilm
ARMsExperimental
DescriptionTenofovir Gel 40 mg inserted vaginally, administered for 7 daily doses
Mode of DeliveryFilm
ARMsExperimental
Results: FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir
Official Code: NCT01989663
Trial Sponsors: CONRAD
Start Date
End Date
November 11, 2013
January 1, 2015
Enrollment:78
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women