Effects of Flourish HEC on Localized Provoked Vulvodynia (NCT05478746) | Clinical Trial Compass
CompletedNot Applicable
Effects of Flourish HEC on Localized Provoked Vulvodynia
United States7 participantsStarted 2022-09-26
Plain-language 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.
Who can participate
Age range
18 Years – 52 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Known allergies or sensitivities to aloe or any other ingredients of the Flourish HEC Vaginal Care System
. Individuals whose pain completely prevents application of intravaginal products (applicators similar in size to a tampon)
. Individuals who are immunosuppressed or otherwise immunocompromised
. Known allergy or sensitivity to metronidazole or fluconazole
. Known active vaginal infection at the beginning of the study
. Anyone who may have mental health disorders or trauma history triggered by answering questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products
. Vulnerable populations: adults unable to consent, individuals who are not yet adults, pregnant or lactating women (or those attempting to become pregnant), and prisoners
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaginal microbiome in women with localized provoked vulvodynia (LPV)
Timeframe: Baseline
2
Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC
Timeframe: Baseline to 6 weeks.
3
Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC
Timeframe: Baseline to 3 months.
4
Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC
Timeframe: 6 weeks to 3 months.
5
Pain intensity by cotton swab test
Timeframe: Baseline to 2 weeks to 6 weeks to 3 months.
6
Vulvovaginal symptoms questionnaire (VSQ) and addendum
Timeframe: Baseline to 2 weeks to 6 weeks to 3 months.