NCT05713435

Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors

Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of Genitourinary Syndrome of Menopause (GSM) in Patients Using Aromatase Inhibitors: Double Blinded Randomized Controlled Clinical Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2 LR, Monalisa Touch; DEKA, Florence, Italy) and non-ablative photothermal Erbium:YAG laser (Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) - with sham vaginal applications for treatment of vaginal dryness as the leading symptom in breast cancer patients with iatrogenic menopause and treated with an AI.

Conditions

• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
DEVICE	intravaginal laser	application of intravaginal laser

Timeline

• Start date: 2022-12-27
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-02-06
• Last updated: 2024-07-01

Locations

1 site across 1 country: Belgium