Clinical trial · Interventional
Vaginal Laser Therapy in Breast Cancer Survivors
Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
NCT03738605CI-TRIAL-00039810unknownN/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)
This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Dyspareunia | — | UNRESOLVED | — |
| Genitourinary Syndrome of Menopause | — | UNRESOLVED | — |
| Vaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microablative Fractional CO2 Laser Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laser Group
- description
- Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)
- interventionNames
- Device: Microablative Fractional CO2 Laser Therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.
- interventionNames
- Device: Microablative Fractional CO2 Laser Therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * breast cancer history * dyspareunia * dryness Exclusion Criteria: * Active genital infection (i.e herpes, vaginitis) * Prolapse stage \>=2 * Underlying pathologies that could interfere with the protocol compliance
References
Publications (0)
Data not yet available
No reference posted for this study.