Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-23 @ 10:13 PM
Study NCT ID:
NCT06668012
Status:
None
Last Update Posted:
2025-02-03 00:00:00
First Post:
2024-10-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Sponsor:
None
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:
None
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:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: