Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03628092
Status:
UNKNOWN
Last Update Posted:
2020-03-12
First Post:
2018-08-01
Brief Title:
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Sponsor:
Royal North Shore Hospital
Organization:
Royal North Shore Hospital
Study Overview
Official Title:
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
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:
LAAVA2
Brief Summary:
To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy VVA or genitourinary syndrome of menopause GSM in women with breast cancer
Detailed Description:
LAAVA 2 is a double blinded randomised placebosham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer Patients will be randomly assigned in a 11 ratio to either active laser treatment or inactive sham laser treatment setting of close to zero
Participants will receive the 3 treatments approximately 4 weeks apart Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment At the twelve week follow up visit after completion of study procedures patients will be unblinded and those who received sham treatment will be allowed to crossover to active treatment if they wish
Participants will receive the 3 treatments approximately 4 weeks apart Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment At the twelve week follow up visit after completion of study procedures patients will be unblinded and those who received sham treatment will be allowed to crossover to active treatment if they wish
Study Oversight
Has Oversight DMC:
None
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?:
None