Status:
COMPLETED
Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations
Lead Sponsor:
Katherine Bunge
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Safety
Acceptability
Eligibility:
FEMALE
18-45 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04391036
Start Date
July 14 2020
End Date
October 26 2020
Last Update
February 22 2022
Active Locations (1)
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1
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213