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Behavioural Intervention

BioNourish for Vulvodynia

N/A

Waitlist Available

Led By Mary Ojo-Carons, MD

Research Sponsored by Vaginal Biome Science

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Premenopausal cis women between ages 18 and 52 diagnosed with LPV via cotton swab test who have experienced symptoms for at least three months, and who do not have another diagnosis which may explain the pain.

Premenopausal cis women between ages 18 and 52 diagnosed with LPV via cotton swab test who have experienced symptoms for at least three months, and who do not have another diagnosis which may explain the pain.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 2 weeks to 6 weeks to 3 months.

Awards & highlights

Study Summary

This trial is testing whether improving the vaginal microbiome helps improve pain in women with vulvodynia better than routine care alone.

Who is the study for?

This trial is for premenopausal cis women aged 18-52 with localized provoked vulvodynia (LPV) diagnosed by a cotton swab test, experiencing symptoms for over three months. Participants should not have other conditions explaining the pain or be allergic to metronidazole/fluconazole, pregnant, lactating, immunocompromised, or unable to apply intravaginal products.Check my eligibility

What is being tested?

The study tests if BioNourish (part of Flourish HEC kit) plus routine care improves vaginal microbiome and reduces pain in LPV patients compared to routine care alone. Women are randomly assigned to either group and evaluated on vaginal health and pain at various intervals up to 3 months.See study design

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to allergies or sensitivities towards ingredients in the Flourish HEC Vaginal Care System like aloe. Routine care side effects depend on standard treatments used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 2 weeks to 6 weeks to 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 2 weeks to 6 weeks to 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 weeks to 6 weeks to 3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC

Pain

Vaginal microbiome in women with localized provoked vulvodynia (LPV)

+1 more

Secondary outcome measures

Treatment escalation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Routine CareExperimental Treatment1 Intervention

Participants enrolled in the control arm will undergo routine care for localized provoked vulvodynia according to the doctor's usual recommendations. These may include lidocaine cream, physical therapy, a compounded cream containing a blend of lidocaine, baclofen, amitryptyline, estradiol, testosterone, and bupivacaine, radiofrequency treatment, Naropin or botulinum toxin injections.

Group II: Flourish HECExperimental Treatment1 Intervention

Participants in the Flourish HEC arm will undergo routine care as described for the control arm. Instead of lidocaine cream, they will be given a 4% lidocaine gel (called "Relief", to be used up to 4x/day as needed) in an iso-osmotic, pH-balanced gel base. In addition, they will be given 3 products to use as described here, comprising the "Flourish HEC" kit (HEC = hydroxyethylcellulose, the principal gelling compound in the vaginal gel, to distinguish from the original Flourish kit using aloe). "Balance" - external vulvar wash to be used daily in the shower. "BioNourish" - vaginal moisturizing gel to be used every day before bed. Iso-osmotic and pH-adjusted with lactic acid to match healthy vaginal fluid. "BiopHresh" - vaginal homeopathic suppository with 7 vaginal probiotic strains, including Lactobacillus crispatus, to be used every 3rd day before bed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BioNourish, a component of the Flourish HEC kit

2022

N/A

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vaginal Biome ScienceLead Sponsor

8 Previous Clinical Trials

167 Total Patients Enrolled

Sexual Health and Wellness InstituteLead Sponsor

8 Previous Clinical Trials

167 Total Patients Enrolled

EvvyUNKNOWN

Media Library

Flourish HEC (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05478746 — N/A

Vulvodynia Research Study Groups: Routine Care, Flourish HEC

Vulvodynia Clinical Trial 2023: Flourish HEC Highlights & Side Effects. Trial Name: NCT05478746 — N/A

Flourish HEC (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478746 — N/A

Vulvodynia Patient Testimony for trial: Trial Name: NCT05478746 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program permit seniors above the age of eighty-five to participate?

"This clinical trial's requirements for eligibility stipulate that the lower limit of age is 18 and the upper boundary is 52."

Answered by AI

Is this investigation still open for enrolment?

"The findings on clinicaltrials.gov reveal that this specific medical study is not currently looking for participants, as the trial launched on September 26th 2022 and was last updated October 4th of the same year. However, there are 13 other trials actively seeking patients at present."

Answered by AI

Who is eligible to join the research project?

"In order to be considered a viable participant, individuals must have been clinically diagnosed with vulvar diseases and should not exceed the upper age limit of 52 years old. This trial is looking to enroll approximately 40 patients."

Answered by AI