Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-01 @ 5:05 AM
Study NCT ID:
NCT06668012
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Sponsor:
Procare Health Iberia S.L.
Organization:
Study Overview
Official Title:
A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISPALOMA
Brief Summary:
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.
Detailed Description:
Multicenter, open, comparative study, where all eligible patients with vaginal dysbiosis (vaginal pH \>4.5) will be assigned to one of the 3 study groups (1:1:1) according to the randomization list for random assignment to groups B and C:
A. Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up
2 visits will be made throughout the study: visit 1 (initial visit, between days 9 and 15 of the menstrual cycle) and visit 2 (final visit, within 5 days after the end of treatment or equivalent in the case of the monitored follow-up group, always before the next menstruation).
The study will consist of two phases; the first phase or PILOT, where 30 patients (10 per group) will be included with the intervention of 2 centers, and a second phase or EXTENSION, where 60 additional patients (20 per group) will be included, obtaining a total of 90 patients (30 per group) at the end of the study.
A. Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up
2 visits will be made throughout the study: visit 1 (initial visit, between days 9 and 15 of the menstrual cycle) and visit 2 (final visit, within 5 days after the end of treatment or equivalent in the case of the monitored follow-up group, always before the next menstruation).
The study will consist of two phases; the first phase or PILOT, where 30 patients (10 per group) will be included with the intervention of 2 centers, and a second phase or EXTENSION, where 60 additional patients (20 per group) will be included, obtaining a total of 90 patients (30 per group) at the end of the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: