Ignite Creation Date:
2024-05-06 @ 1:31 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04042766
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2019-07-31
Brief Title:
Laser Vaginal Treatment for GSM
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Laser Vaginal Treatment for GSM
Status:
RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
Genitourinary Syndrome of Menopause GSM due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on womens quality of life Women complain of vaginal dryness itching discomfort malodour painful intercourse and may have urinary urgency irritation bladderurethral pain and recurring bladder infections First-line therapies include vaginal moisturizers lubricants and estrogen either oral or with vaginal creamtablets While these therapies are effective the ongoing costs and the resistance to the indefinite use of vaginal creamsinserts is a challenge to the continued use of these therapies Recently an innovative laser therapy has been used to treat women with GSM A randomized controlled trial RCT to study how effective the laser is to treat women with GSM is planned
Detailed Description:
None
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