Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations (FAME103B)

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

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.

Study Overview

• Status: Completed
• Conditions: Safety; Acceptability
• Intervention / Treatment: Device: High Eudragit® Content Vaginal Film; Device: Low Eudragit® Content Vaginal Film

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh, Magee Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Eudragit® Film, then Low Eudragit® Film; High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film	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
Experimental: Low Eudragit® Film, then High Eudragit® Film; Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Katherine Bunge
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

General Publications

• 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. doi: 10.1258/0956462981921224.
• 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.
• 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. doi: 10.1016/s0010-7824(99)00060-8.

Helpful Links

• UNAIDS Women and Girls and HIV.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): October 26, 2020
• Study Completion (Actual): October 26, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Extended Release; Vagina; Film
• Other Study ID Numbers: STUDY20040030; 1U19AI120249 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes