Clinical trial · Interventional
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.
NCT05713435CI-TRIAL-00078408LASIunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genitourinary Syndrome of Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intravaginal laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Mona Lisa Touch CO2 laser
- description
- 1. Power: 30 W. 2. Dwell time: 1000 μs. 3. Spacing: 1000 μm. 4. Depth: SmartStack parameter from 1 to 3 depending on the treatment status. 5. D-pulse mode. 6. At the introitus the power will be reduced to 24 W
- interventionNames
- Device: intravaginal laser
- type
- ACTIVE_COMPARATOR
- label
- Fotona Smooth erbium:YAG laser
- description
- 1. Phase I (vaginal) Renovalase™ mode with (a) fluence of 5,5J/cm2, (b) SMOOTHTM mode frequency 1.6 Hz, and (c) spot size 7 mm. 2. Phase II (vestibulum and introitus) Renovalase™ mode with (a) fluence 10 J/cm2, (b) SMOOTHTM mode frequency 1.6Hz, and (c) spot size 7 mm.
- interventionNames
- Device: intravaginal laser
- type
- SHAM_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Recruited participants will meet all of these criteria: * a history of breast cancer * premenopausal at diagnosis of breast cancer * using AI as an adjuvant treatment * moderate to severe symptoms of GSM (VAS ≥ 4/10) * currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial) Exclusion Criteria: * Not willing to abstain from vaginal intercourse for 1 week following laser therapy * Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion * Use of hormonal therapy within 6 months prior to inclusion (systemic or local) * Acute urinary or genital tract infections * A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration * Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System * Previous vaginal mesh implantation * Abnormal result in the last cervical smear (maximum 36 month before enrollment) * Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser) * Vaginal stenosis that does not allow the placement of the laser probe * Any condition that could interfere with study compliance
References
Publications (0)
Data not yet available
No reference posted for this study.