Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations (FAME103B)

Katherine Bunge

Status: Completed

Conditions: Acceptability; Safety

Treatments: Device: High Eudragit® Content Vaginal Film; Device: Low Eudragit® Content Vaginal Film

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04391036

STUDY20040030

1U19AI120249 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

High Eudragit® Film, then Low Eudragit® Film

Experimental group

Description:

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

Treatment:

Device: High Eudragit® Content Vaginal Film

Device: Low Eudragit® Content Vaginal Film

Low Eudragit® Film, then High Eudragit® Film

Experimental group

Description:

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

Treatment:

Device: High Eudragit® Content Vaginal Film

Device: Low Eudragit® Content Vaginal Film