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Effects of Flourish HEC on Localized Provoked Vulvodynia

NCT05478746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-02-06

No results posted yet for this study

Summary

This study is designed to determine whether improving the vaginal microbiome in women with localized provoked vulvodynia (LPV) may help improve pain better than routine care alone. The study randomizes women with LPV to either routine care or routine care plus a vaginal hygiene system designed to improve the vaginal microbiome. Women will be assessed for vaginal microbiome, vaginal pH, and pain before enrollment and after 6 weeks, and after 3 months. Women will also have pain assessed 2 weeks after enrollment without assessing vaginal microbiome and pH.

Conditions

  • Vulvodynia
  • Vestibulodynia
  • Vulvar Diseases
  • Vulvar Vestibulitis
  • Vulvar Pain

Interventions

DEVICE

BioNourish, a component of the Flourish HEC kit

BioNourish is a vaginal moisturizing gel which obtained FDA 510k clearance in 2020. It is one component of the full system being tested. The main intervention is to use this kit to improve the vaginal microbiome.

OTHER

Control - no intervention

No intervention; participants only receive routine care.

Sponsors & Collaborators

  • Evvy

    collaborator UNKNOWN

  • Vaginal Biome Science

    lead OTHER

Principal Investigators

  • Mary Ojo-Carons, MD · EvoScient Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2024-01-15
Completion
2024-01-15
FDA Device
Yes

Countries

  • United States

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 NCT05478746 on ClinicalTrials.gov