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NCT05478746
Effects of Flourish HEC on Localized Provoked Vulvodynia
NA trial testing BioNourish, a component of the Flourish HEC kit in Vulvodynia in 7 participants. Completed in 15 January 2024.
15 January 2024
Quick facts
| Lead sponsor | Vaginal Biome Science |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 26 September 2022 |
| Primary completion | 15 January 2024 |
| Estimated completion | 15 January 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- BioNourish, a component of the Flourish HEC kit
- Control - no intervention
Conditions studied
- Vulvodynia — all drugs for Vulvodynia →
- Vestibulodynia — all drugs for Vestibulodynia →
- Vulvar Diseases — all drugs for Vulvar Diseases →
- Vulvar Vestibulitis — all drugs for Vulvar Vestibulitis →
Sponsor
Vaginal Biome Science
Who can join
Adults 18 to 52, female only, with Vulvodynia or Vestibulodynia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05478746
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vulvodynia
Currently open trials in the same condition.
- NCT07257029 — Topical Ketotifen 0.25% for Secondary Vestibulodynia · Phase 2 · recruiting
- NCT07391241 — A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia) · Phase 2 · recruiting
- NCT07092332 — Young Vulvodynia: Effect and Efficacy of Multimodal Treatment. · NA · recruiting
- NCT06865963 — Vestibulodynia At High Resolution: Omics Approach to Improve Diagnosis · recruiting
- NCT05955313 — Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia · Phase 2 · recruiting
Other Vaginal Biome Science trials
Trials by the same sponsor.
- NCT06472765 — Vaginal Ecosystem and Network in the United States Study · enrolling by invitation
- NCT05573334 — Vaginal Care System for Menopausal Women With Urinary Tract Infections · NA · completed
- NCT05701722 — Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome · NA · completed
- NCT05665569 — Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders · NA · terminated
- NCT05397782 — Effects of Flourish on Recurrent Urinary Tract Infection · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05478746 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vaginal Biome Science
- Last refreshed: 6 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05478746.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing