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SafetyFAME103BNCT04391036

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

A study testing High Eudragit® Content Vaginal Film and Low Eudragit® Content Vaginal Film in people with Safety and Acceptability, run by Katherine Bunge at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Safety, Acceptability
What is being tested?
High Eudragit® Content Vaginal Film and Low Eudragit® Content Vaginal Film
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
14 Jul 2020to 26 Oct 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh, Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
High Eudragit® Content Vaginal Film, Low Eudragit® Content Vaginal Film
Keywords
Vagina, Film, Extended Release

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Eudragit® Content Vaginal FilmDevice

    High (12.8%) Eudragit® Content Vaginal Film

  • Low Eudragit® Content Vaginal FilmDevice

    Low (6.4%) Eudragit® Content Vaginal Film

Study groups in NCT04391036
Study groupRoleWhat they receive
High Eudragit® Film, then Low Eudragit® FilmExperimentalHigh (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film
Receives: Device: High Eudragit® Content Vaginal Film; Device: Low Eudragit® Content Vaginal Film
Low Eudragit® Film, then High Eudragit® FilmExperimentalLow (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film
Receives: Device: High Eudragit® Content Vaginal Film; Device: Low Eudragit® Content Vaginal Film

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Approximately 30 minutes

Secondary outcomes (2)

  1. 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)

    Measured: Approximately 30 minutes

  2. 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.

    Measured: Approximately 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start14 Jul 2020
  3. Primary completion26 Oct 2020
  4. Study completion26 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391036
Sponsor's protocol ID
STUDY20040030
Other IDs
1U19AI120249
Acronym
FAME103B
Status last verified
Feb 2022
First submitted
12 May 2020
Last updated
22 Feb 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 9863584

  • 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.

    PubMed 21774672

  • 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.

    PubMed 10549452

Questions about this trial

What is this clinical trial studying?

A study testing High Eudragit® Content Vaginal Film and Low Eudragit® Content Vaginal Film in people with Safety and Acceptability, run by Katherine Bunge at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants That Successfully Insert Vaginal Film (time frame: Approximately 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04391036, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.

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