NCT04841629

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

April 8, 2021

Last Update Submit

December 4, 2022

Conditions

Sensory Perceptual CharacteristicsUser Acceptability of Gel Delivery System

Outcome Measures

Primary Outcomes (2)

  • Sensory perceptual characteristics of gels based on forearm testing

    1 hour

  • User acceptability of gel delivery system

    1 hour

Study Arms (3)

PreBioGyn Gel

EXPERIMENTAL

Topical administration to forearm

Other: PreBioGyn Gel

Trimosan Gel

ACTIVE COMPARATOR

Topical administration to forearm

Other: Trimosan Gel

RepHresh Gel

ACTIVE COMPARATOR

Topical administration to forearm

Other: RepHresh Gel

Interventions

PreBioGyn GelOTHER

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

PreBioGyn Gel
Trimosan GelOTHER

Carbomer-based gel

Trimosan Gel
RepHresh GelOTHER

Carbomer-based gel

RepHresh Gel

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • hrHPV positive
  • years of age or older
  • Have not received the HPV vaccine
  • Not pregnant or nursing
  • Medicaid eligible

You may not qualify if:

  • history of skin irritation and/or allergic skin reactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women'S Hospital

Boston, Massachusetts, 02215, United States

Location

University of Puerto Rico Medical Sciences

San Juan, 00936, Puerto Rico

Location

Study Officials

  • Joanna Ellington, PhD

    Glyciome, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 12, 2021

Study Start

February 24, 2022

Primary Completion

November 28, 2022

Study Completion

November 28, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)PR(1)