Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations

Study Overview
=================
Brief Summary
-----------------
This is a double-blinded crossover study to evaluate whether Eudragit® content impacts the ability to self-insert placebo vaginal films. Thirty women will self-insert one high and and one low Eudragit® content film. The insertion order will be randomized in a 1:1 ratio. After inserting each film, participants will complete a survey reporting their perceptions and experience. The primary endpoint is successful insertion defined as all of the film inside the vagina upon visual assessment by a study clinician. Secondary outcomes include preference for the low level or high level Eudragit® formulation film with respect to insertion and participants' description of identified challenges.

Detailed Description
-----------------
This is a double-blinded crossover study to evaluate whether ammonio methacrylate copolymer dispersion type B (Eudragit®) content impacts the ability to self-insert placebo vaginal films. Eudragit® is a commonly used pharmaceutical excipient, present in several FDA approved products. This hydrophobic excipient is used in vaginal film formulations to increase disintegration time and impart extended drug release property. The presence of Eudragit and its concentration level affects film disintegration and spreadability in the vaginal environment, and are likely to affect tactile properties. Consequently, these attributes may impact ease of film administration, acceptability, and user preferences for specific film type. Thirty pre-menopausal women, 18 - 45 years of age, will self-insert one high and and one low Eudragit® content film. High and low Eudragit films correspond to 12.8% and 6.4% of Eudragit® added during the formulation blending stage. The insertion order will be randomized in a 1:1 ratio. Within 10 minutes of the insertion, clinical staff will perform a speculum exam to assess the location of the film and remove the residual film. After inserting each film, participants will complete a survey reporting their perceptions and experience. The primary endpoint is successful insertion defined as all of the film inside the vagina upon visual assessment by a study clinician. Secondary outcomes include preference for the low level or high level Eudragit® formulation film with respect to insertion and participants' description of identified challenges.

Official Title
-----------------
A Randomized Double-Blind Cross-Over Study of Self-Insertion of Two Formulations of a Placebo Vaginal Film

Conditions
-----------------
Safety, Acceptability

Intervention / Treatment
-----------------
* Device: High Eudragit® Content Vaginal Film
* Device: Low Eudragit® Content Vaginal Film


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-45 Intact uterus by participant report Agrees to abstain from inserting anything into the vagina for 24 hours prior to the study visit Exclusion Criteria: Menopausal (as defined as amenorrhea for one year or more without an alternative etiology) Hysterectomy (including total and supracervical) Currently pregnant or pregnancy within 90 days of enrollment Lactating Symptoms of a urogenital infection including vaginal discharge, pain, odor, or itching Menses at the time of enrollment Known allergy or hypersensitivity to any of the components of the placebo film Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant will self-insert one low level Eudragit® and one high level Eudragit® formulation film. The sequence of insertion will be randomized in a 1:1 ratio.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Eudragit® Film, then Low Eudragit® Film<br>High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film | Device: High Eudragit® Content Vaginal Film<br>* High (12.8%) Eudragit® Content Vaginal Film<br>Device: Low Eudragit® Content Vaginal Film<br>* Low (6.4%) Eudragit® Content Vaginal Film<br>|
| Experimental: Low Eudragit® Film, then High Eudragit® Film<br>Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film | Device: High Eudragit® Content Vaginal Film<br>* High (12.8%) Eudragit® Content Vaginal Film<br>Device: Low Eudragit® Content Vaginal Film<br>* Low (6.4%) Eudragit® Content Vaginal Film<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Successfully Insert Vaginal Film | Number of participants that successfully insert each vaginal film defined as the film location being completely inside the vagina upon visual assessment by a clinician | Approximately 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Report Self-Insertion of Vaginal Film Was Easy | Participants that report that self-insertion of the placebo vaginal film was not difficult at all as assessed on a Likert scale from 1 (not difficult at all) to 4 (very difficult) | Approximately 30 minutes | 
| Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film | Number of participants that report that they would prefer to use the high Eudragit® content vaginal film over the low Eudragit® content vaginal film. This outcome was analyzed by order of film product use (high then low vs low then high) as this may influence product preference. | Approximately 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vagina, Film, Extended Release