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

Safety Clinical Trial

— FAME103B  

Official title:

A Randomized Double-Blind Cross-Over Study of Self-Insertion of Two Formulations of a Placebo Vaginal Film

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391036
• Other study ID #: STUDY20040030
• Secondary ID: 1U19AI120249
• Status: Completed
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: October 26, 2020

Study information

• Verified date: February 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acceptability
• Safety

Intervention

Device:
• High Eudragit® Content Vaginal Film
High (12.8%) Eudragit® Content Vaginal Film
• Low Eudragit® Content Vaginal Film
Low (6.4%) Eudragit® Content Vaginal Film

Locations

Country	Name	City	State
United States	University of Pittsburgh, Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Katherine Bunge	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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

External Links

•   UNAIDS Women and Girls and HIV.