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

NCT04391036 | Completed Results FDA Device

• 2 other identifiers: STUDY200400301U19AI120249
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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® 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

Keywords

Vagina; Film; Extended Release

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants That Report Self-Insertion of Vaginal Film Was Easy

  Approximately 30 minutes

• Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film

  Approximately 1 hour

Study Arms (2)

High Eudragit® Film, then Low Eudragit® Film

EXPERIMENTAL

High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film

Device: High Eudragit® Content Vaginal Film; Device: Low Eudragit® Content Vaginal Film

Low Eudragit® Film, then High Eudragit® Film

EXPERIMENTAL

Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film

Device: High Eudragit® Content Vaginal Film; Device: Low Eudragit® Content Vaginal Film

Interventions

High Eudragit® Content Vaginal Film DEVICE

High (12.8%) Eudragit® Content Vaginal Film

High Eudragit® Film, then Low Eudragit® Film; Low Eudragit® Film, then High Eudragit® Film

Low Eudragit® Content Vaginal Film DEVICE

Low (6.4%) Eudragit® Content Vaginal Film

High Eudragit® Film, then Low Eudragit® Film; Low Eudragit® Film, then High Eudragit® Film

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Katherine Bunge: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Pittsburgh, Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 9863584 BACKGROUND

• 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.

  PMID: 21774672 BACKGROUND

• 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.

  PMID: 10549452 BACKGROUND

Related Links

• UNAIDS Women and Girls and HIV.

Results Point of Contact

• Title: Dr. Leslie Meyn
• Organization: University of Pittsburgh Medical School

meynla@mwri.magee.edu

412-641-4233

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Katherine Bunge, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants, clinicians, and assessors of the study outcomes will be blinded to Eudragit® content of the film.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each participant will self-insert one low level Eudragit® and one high level Eudragit® formulation film. The sequence of insertion will be randomized in a 1:1 ratio.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 18, 2020
• Study Start: July 14, 2020
• Primary Completion: October 26, 2020
• Study Completion: October 26, 2020
• Last Updated: February 22, 2022
• Results First Posted: November 22, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)