Safety Clinical Trial
— FAME103BOfficial title:
A Randomized Double-Blind Cross-Over Study of Self-Insertion of Two Formulations of a Placebo Vaginal Film
Verified date | February 2022 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 26, 2020 |
Est. primary completion date | October 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh, Magee Womens Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Katherine Bunge | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Nel AM, Mitchnick LB, Risha P, Muungo LT, Norick PM. Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women. J Womens Health (Larchmt). 2011 Aug;20(8):1207-14. doi: 10.1089/jwh.2010.2476. Epub 2011 Jul 20. — View Citation
Raymond E, Alvarado G, Ledesma L, Diaz S, Bassol S, Morales E, Fernandez V, Carlos G. Acceptability of two spermicides in five countries. Contraception. 1999 Jul;60(1):45-50. — View Citation
Visness CM, Ulin P, Pfannenschmidt S, Zekeng L. Views of Cameroonian sex workers on a woman-controlled method of contraception and disease protection. Int J STD AIDS. 1998 Nov;9(11):695-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants That Successfully Insert Vaginal Film | Number of participants that successfully insert each vaginal film defined as the film location being completely inside the vagina upon visual assessment by a clinician | Approximately 30 minutes | |
Secondary | Number of Participants That Report Self-Insertion of Vaginal Film Was Easy | Participants that report that self-insertion of the placebo vaginal film was not difficult at all as assessed on a Likert scale from 1 (not difficult at all) to 4 (very difficult) | Approximately 30 minutes | |
Secondary | Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film | Number of participants that report that they would prefer to use the high Eudragit® content vaginal film over the low Eudragit® content vaginal film. This outcome was analyzed by order of film product use (high then low vs low then high) as this may influence product preference. | Approximately 1 hour |
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