Comparison of Tenofovir Vaginal Gel and Film Formulations (FAME-05)
Status:Completed
Phase:Open Label
Principal Investigator(s):
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:Open label, Randomized
Arms and Assigned Interventions
DescriptionWomen 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 DeliveryGel
ARMsExperimental
DescriptionWomen 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 DeliveryFilm
ARMsExperimental
Official Code:
NCT02280109
Trial Sponsors:
CONRAD
Start Date
End Date
November 11, 2014
December 1, 1015
Enrollment:10
Age range:
18 Years ↔
45 Years
Population:Cisgender Women