RecruitingNot ApplicableNCT05713435

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.


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

162 participants

Start Date

Dec 27, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of vaginal laser treatment — fractional CO2 laser and erbium:YAG laser — for managing genitourinary syndrome of menopause (GSM), which causes vaginal dryness, pain, and urinary symptoms, in women with breast cancer who are taking aromatase inhibitors (hormone-blocking drugs). **You may be eligible if...** - You have a history of breast cancer and were premenopausal at diagnosis - You are currently taking an aromatase inhibitor as part of your ongoing breast cancer treatment - You are currently menopausal (whether from chemotherapy, surgery, or medication) - You have moderate to severe GSM symptoms (vaginal dryness, pain, or discomfort rated 4 or higher on a 10-point scale) **You may NOT be eligible if...** - You are unwilling to avoid vaginal intercourse for 1 week after each laser session - You used non-hormonal vaginal products in the last 6 weeks - You used hormone therapy (local or systemic) in the past 6 months - You have a genital infection, vaginal prolapse grade 2 or higher, or vaginal mesh - You are still actively undergoing radiation or chemotherapy - You have vaginal narrowing that prevents laser probe insertion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEintravaginal laser

application of intravaginal laser


Locations(1)

UZ Leuven

Leuven, Flemish Brabant, Belgium

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NCT05713435


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