BioNourish, a component of the Flourish HEC kit for Vulvar Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
EvoScient Gynecology, Virginia Beach, VA
Vulvar Diseases+4 More
BioNourish, a component of the Flourish HEC kit - Device
Eligibility
18 - 65
Female
What conditions do you have?
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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.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: Baseline to 2 weeks to 6 weeks to 3 months.

Month 3
Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC
Baseline
Vaginal microbiome in women with localized provoked vulvodynia (LPV)
Month 3
Pain intensity by cotton swab test
Treatment escalation
Vulvovaginal symptoms questionnaire (VSQ) and addendum

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Flourish HEC
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: BioNourish, a component of the Flourish HEC kit · No Placebo Group · N/A

Flourish HEC
Device
Experimental Group · 1 Intervention: BioNourish, a component of the Flourish HEC kit · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 2 weeks to 6 weeks to 3 months.
Closest Location: EvoScient Gynecology · Virginia Beach, VA
Photo of virginia 1Photo of virginia 2Photo of virginia 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Vulvar Diseases
0 CompletedClinical Trials

Who is running the clinical trial?

Sexual Health and Wellness InstituteLead Sponsor
5 Previous Clinical Trials
178 Total Patients Enrolled
EvvyUNKNOWN
Vaginal Biome ScienceUNKNOWN
Mary Ojo-Carons, MDPrincipal InvestigatorEvoScient Gynecology

Eligibility Criteria

Age 18 - 65 · Female Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References