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Perception & Acceptability of a Cervical Cancer Prevention Prebiotic Device

NCT04841629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-12-06

No results posted yet for this study

Summary

PreBioGyn will be compared to market leading vaginal pH buffering gels using established forearm test methods associated with vaginal lubricity sensation in 42 women. Women will also rate each gel for smell and appearance using established methods. The PreBioGyn gel enclosure and intravaginal applicator design will be evaluated for: look and feel, ability to prepare for dosing, ability to expulse dose, and likelihood of future use by subjects. Open-ended feedback on the gel and applicator will occur to gather contributions for each product.

Conditions

  • Sensory Perceptual Characteristics
  • User Acceptability of Gel Delivery System

Interventions

OTHER

PreBioGyn Gel

Cellulose-based prebiotic gel developed to optimize vaginal health and reduce the risk of cervical cancer in women.

OTHER

Trimosan Gel

Carbomer-based gel

OTHER

RepHresh Gel

Carbomer-based gel

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • University of Puerto Rico

    collaborator OTHER

  • Glyciome, LLC

    lead INDUSTRY

Principal Investigators

  • Joanna Ellington, PhD · Glyciome, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2022-11-28
Completion
2022-11-28

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841629 on ClinicalTrials.gov