MedTrace Logo

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

NCT04391036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-22

Study results available
· View outcomes & findings →

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.

Conditions

  • Safety
  • Acceptability

Interventions

DEVICE

High Eudragit® Content Vaginal Film

High (12.8%) Eudragit® Content Vaginal Film

DEVICE

Low Eudragit® Content Vaginal Film

Low (6.4%) Eudragit® Content Vaginal Film

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Katherine Bunge

    lead OTHER

Principal Investigators

  • Sharon L Hillier, PhD · University of Pittsburgh

  • Katherine Bunge, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2020-10-26
Completion
2020-10-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391036 on ClinicalTrials.gov