Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-29 @ 10:46 AM
Study NCT ID:
NCT04711369
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2020-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lasertherapy for Vulvodynia
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
Lasertherapy for Vulvodynia
Status:
RECRUITING
Status Verified Date:
2025-03
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:
Lydia
Brief Summary:
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Detailed Description:
Randomized double blinded sham-controlled clinical study
Main hypothesis:
Laser therapy will be more effective than sham laser therapy in vulvar pain reduction measured by Q-tip test and tampon test
Secondary study hypotheses Laser therapy, in comparison to sham laser therapy
* will lead to more improvement of Sexual Health and HrQoL
* will have similar rates of side effects
Main hypothesis:
Laser therapy will be more effective than sham laser therapy in vulvar pain reduction measured by Q-tip test and tampon test
Secondary study hypotheses Laser therapy, in comparison to sham laser therapy
* will lead to more improvement of Sexual Health and HrQoL
* will have similar rates of side effects
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?:
False
Is an FDA AA801 Violation?: