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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2020-10-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Safety Acceptability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The participants, clinicians, and assessors of the study outcomes will be blinded to Eudragit® content of the film.

Study Groups

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High Eudragit® Film, then Low Eudragit® Film

High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film

Group Type EXPERIMENTAL

High Eudragit® Content Vaginal Film

Intervention Type DEVICE

High (12.8%) Eudragit® Content Vaginal Film

Low Eudragit® Content Vaginal Film

Intervention Type DEVICE

Low (6.4%) Eudragit® Content Vaginal Film

Low Eudragit® Film, then High Eudragit® Film

Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film

Group Type EXPERIMENTAL

High Eudragit® Content Vaginal Film

Intervention Type DEVICE

High (12.8%) Eudragit® Content Vaginal Film

Low Eudragit® Content Vaginal Film

Intervention Type DEVICE

Low (6.4%) Eudragit® Content Vaginal Film

Interventions

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High Eudragit® Content Vaginal Film

High (12.8%) Eudragit® Content Vaginal Film

Intervention Type DEVICE

Low Eudragit® Content Vaginal Film

Low (6.4%) Eudragit® Content Vaginal Film

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes