Actively Recruiting
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
162
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer
CONDITIONS
Official Title
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of breast cancer
- Premenopausal at breast cancer diagnosis
- Currently using aromatase inhibitors as adjuvant treatment
- Moderate to severe genitourinary syndrome of menopause symptoms (VAS 64 4/10)
- Currently menopausal due to biochemical, surgical, or medicinal causes (including GnRH analogues during the trial)
You will not qualify if you...
- Not willing to abstain from vaginal intercourse for 1 week after laser therapy
- Use of non-hormonal vaginal products within 6 weeks before joining
- Use of hormonal therapy (systemic or local) within 6 months before joining
- Presence of acute urinary or genital infections
- History of genital fistula, thin rectovaginal septum, or severe vaginal laceration
- Pelvic organ prolapse grade 2 or higher
- Previous vaginal mesh implantation
- Abnormal cervical smear within 36 months before joining
- Ongoing or planned active cancer treatment before primary outcome assessment
- Vaginal stenosis preventing laser probe placement
- Any condition interfering with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
Research Team
S
Susanne Housmans, MD
CONTACT
J
Jan Deprest, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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