CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Vaginal Filmdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03537092
NCT03537092N/ACompleted
CompareCT.gov

A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101

Katherine Bunge·interventional·Posted May 25, 2018·Updated Jan 13, 2020

In Brief

A clinical study evaluating Vaginal Film for Safety of Vaginal Film Use. Completed, enrolled 64 participants across 1 site.

Detailed Summary

This is a phase I randomized trial assessing the safety of a single vaginal placebo film application. In order to develop a vaginal film which can provide extended release of an Antiretroviral (ARV), the film polymers and formulation have been altered from the cellulose and polyvinyl alcohol films used to deliver dapivirine and tenofovir in previous trials. Therefore, the proposed study will evaluate the safety and persistence of these film polymers when applied vaginally.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety of Vaginal Film Use
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 25, 2018
Enrollment StartMay 22, 2018
Primary CompletionDec 4, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.1 years ago

Interventions

Vaginal Filmdevice

2" x 2" vaginal film with no active drug