NCT03537092: FAME101

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

Completed NA Results posted Last updated 13 January 2020

What this trial tests

NA trial testing Vaginal Film in Safety of Vaginal Film Use in 64 participants. Completed in 4 December 2018.

Timeline

22 May 2018

Primary endpoint
4 December 2018

4 December 2018

Quick facts

Lead sponsor	Katherine Bunge
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	64
Start date	22 May 2018
Primary completion	4 December 2018
Estimated completion	4 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Vaginal Film

Conditions studied

• Safety of Vaginal Film Use — all drugs for Safety of Vaginal Film Use →

Sponsor

Katherine Bunge

Who can join

Adults 18 to 45, female only, with Safety of Vaginal Film Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Grade 2 or Higher Urogenital System Adverse Event Related to Film Use Primary · 30 days

Any urogenital adverse event that occurs with a severity of Grade 2 (moderate) or higher that is deemed to be related to product use by the clinical primary investigator

Group	Value	95% CI
Vaginal Film	2

Correct Insertion of Vaginal Film Secondary · 30 days

Vaginal film was correctly inserted by the participant as assessed by clinical investigator

Group	Value	95% CI
Vaginal Film	47

Difficulty of Vaginal Film Insertion Secondary · 30 days

The perceived difficulty of vaginal film insertion by the participant will be assessed on a 4 point Likert scale

Very difficult

Group	Value	95% CI
Vaginal Film	8

Moderately difficult

Group	Value	95% CI
Vaginal Film	11

Slightly difficult

Group	Value	95% CI
Vaginal Film	28

Easy

Group	Value	95% CI
Vaginal Film	16

Acceptability of Vaginal Film Use Secondary · 30 days

The acceptability of vaginal film use by the participant will be assessed on a 5 point Likert scale

Do not agree at all

Group	Value	95% CI
Vaginal Film	4

Agree a little

Group	Value	95% CI
Vaginal Film	6

Agree somewhat

Group	Value	95% CI
Vaginal Film	8

Agree a lot

Group	Value	95% CI
Vaginal Film	20

Agree completely

Group	Value	95% CI
Vaginal Film	26

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vaginal Film

Serious: 0/64 (0%)

Deaths: 0/64

Other adverse events (5 terms — click to expand)

Reaction	System	Vaginal Film
Vaginal discharge	Reproductive system and breast disorders	—
Pelvic pain	Reproductive system and breast disorders	—
Bleeding abnormality	Reproductive system and breast disorders	—
Genital itching	Reproductive system and breast disorders	—
Vaginal infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT03537092 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.