Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
Study NCT ID:
NCT04021966
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2019-07-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
Sponsor:
prof. dr. Jan Deprest
Organization:
Study Overview
Official Title:
Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
Status:
COMPLETED
Status Verified Date:
2022-01
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:
CO2VVA
Brief Summary:
Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.
Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).
Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.
Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).
Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: