Clinical trial NCT04391036: Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations
Official title: A Randomized Double-Blind Cross-Over Study of Self-Insertion of Two Formulations of a Placebo Vaginal Film
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety
Acceptability
Keywords: Vagina
Film
Extended Release
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-05-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of Participants That Successfully Insert Vaginal Film
timeFrame: Approximately 30 minutes
Secondary outcomes:
measure: Number of Participants That Report Self-Insertion of Vaginal Film Was Easy
timeFrame: Approximately 30 minutes
measure: Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film
timeFrame: Approximately 1 hour
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sharon L Hillier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Katherine Bunge, MD
role: PRINCIPAL_INVESTIGATOR
References:
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