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Comparison of Tenofovir Vaginal Gel and Film Formulations (FAME-05)

Status
Completed
Phase
Open Label
Objective

This is an open label comparative study of tenofovir gel and film in 10 healthy sexually active women without active female genital tract disorders. The women will receive a single dose of each formulation - tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) and tenofovir film (1.3%;40 mg) - in a crossover study design to determine the pharmacokinetics of tenofovir in the blood, cervical tissue, and cervicovaginal fluid (primary objective).

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Women will receive a single dose of tenofovir gel (1%;equivalent to 40 mg in 4ml's of gel) to determine the pharmacokinetics of tenofovir in the blood, cervical tissue, and cervicovaginal fluid.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Women will receive a single dose of tenofovir film (1.3%;40 mg) to determine the pharmacokinetics of tenofovir in the blood, cervical tissue, and cervicovaginal fluid.
Mode of Delivery
Film
Products
tenofovir
ARMs
Experimental
Trial Sponsors
CONRAD
November 2014
December 1015
Enrollment
10
18
Years
45
Years
Population
Women