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NCT06668012: DISPALOMA
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
NA trial testing Palomacare® vaginal gel is a medical device with CE class IIa. in Vaginal Dysbiosis in 30 participants. Currently enrolling.
20 May 2025
Quick facts
| Lead sponsor | Procare Health Iberia S.L. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 12 December 2024 |
| Primary completion | 20 May 2025 |
| Estimated completion | 31 May 2025 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Palomacare® vaginal gel is a medical device with CE class IIa.
Conditions studied
- Vaginal Dysbiosis — all drugs for Vaginal Dysbiosis →
Sponsor
Procare Health Iberia S.L. — full company profile →
Who can join
Adults 18 to 45, female only, with Vaginal Dysbiosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in order to try to prevent the appearance of future established vaginal infections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06668012
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Procare Health Iberia S.L. trials
Trials by the same sponsor.
- NCT05275244 — Evaluate Clinical Benefit of Local Treatment With KD Intra-Articular® Gel in Patients With Osteoarthritis (NO-DOLOR2) · completed
- NCT04766957 — Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy · NA · completed
- NCT04188600 — Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels · NA · withdrawn
- NCT04124640 — Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction. · completed
- NCT04199078 — Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. · 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 NCT06668012 (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 Procare Health Iberia S.L.
- Last refreshed: 3 February 2025
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/NCT06668012.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing