Effects of Flourish HEC on Localized Provoked Vulvodynia
Completed · Not applicable
Conditions studied: Vulvodynia, Vestibulodynia, Vulvar Diseases, Vulvar Vestibulitis, Vulvar Pain
In brief
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.
Key facts
- Study ID
- NCT05478746
- Run by
- Vaginal Biome Science
- People needed
- 7
- Starts
- 2022-09-26
- Expected to finish
- 2024-01-15
- Last updated by the study team
- 2024-02-06
Who can join
Age: 18 and older, up to 52. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- EvoScient Gynecology — Virginia Beach, Virginia, United States
Full record on ClinicalTrials.gov
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