N/A
N=30
Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations
Safety · Acceptability
Bottom Line
View on ClinicalTrials.gov: NCT04391036 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants That Successfully Insert Vaginal Film — 8; 8; 22; 22 Participants — p=>.99
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Eudragit® Content Vaginal Film (Device); Low Eudragit® Content Vaginal Film (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Katherine Bunge
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Successfully Insert Vaginal Film |
8; 8; 22; 22 | >.99 |
| SECONDARY Number of Participants That Report Self-Insertion of Vaginal Film Was Easy |
11; 8; 19; 22 | .45 |
| SECONDARY Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film |
5; 9; 5; 2; 5; 4 | .26 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04391036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.