Clinical trial · Interventional
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
LASER and Radiofrequency as Alternative Treatment of Vaginal Vulvar Atrophy in Women Treated for Breast Cancer
NCT04081805CI-TRIAL-00088896EPMLARFactive not recruitingN/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 is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.
Conditions
Conditions (3)
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 |
| Vaginal Atrophy | — | UNRESOLVED | — |
| Vulva; Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LASER | Procedure | — | UNRESOLVED |
| Micro Ablative Radiofrequency | Procedure | — | UNRESOLVED |
| Promestriene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- LASER
- description
- The patients will receive 3 consecutive applications of intravaginal and vulvar CO2 LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days
- interventionNames
- Procedure: LASER
- type
- ACTIVE_COMPARATOR
- label
- Micro Ablative Radiofrequency
- description
- The patients will receive 3 consecutive applications of intravaginal and vulvar MIcroablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days
- interventionNames
- Procedure: Micro Ablative Radiofrequency
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy 2. To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of vulvovaginal atrophy: * Burning * Discomfort * Dryness * Cracks * Pruritus * Lack of vaginal lubrication * Penetration dyspareunia that began at the menopausal or postmenopausal transition * Decreased vaginal epithelium turgor and trophism * Deletion of mucous and skin folds. 3. Absence of vaginal surgical procedure in the last year 4. Genital prolapse stage no greater than stage II of Pelvic Organs Prolapse Quantitation (POP-Q) with Ba, Bp or C points less than or equal to 0 Exclusion Criteria: 1. Active genital infection 2. Active infection of HPV (human papillomavirus) or Herpes 3. users of medications with estrogenic effect (digoxin and other chemicals) 4. Postmenopausal genital bleeding 5. uncontrolled diabetes 6. use of multivitamins with zinc 7. use of copper or hormonal IUDs (intrauterine device) at the time of inclusion 8. presence of genitourinary or rectovaginal fistulas
References
Publications (2)
- DERIVEDCantarelli GC, Bianchi-Ferraro AMHM, Dedonatto C, Fernandes MFR, Vanzin RB, Dardes RCM, Logullo AF, de Almeida JS, Facina G, de Jarmy-Di Bella ZIK, Sartori MGF, Patriarca MT; LARF-Study Group. Clinical and histomorphometric evaluation of the vagina following treatment with CO2 laser, radiofrequency, and promestriene for genitourinary syndrome of menopause in breast cancer survivors on adjuvant therapy. Maturitas. 2025 Jan;191:108155. doi: 10.1016/j.maturitas.2024.108155. Epub 2024 Nov 14. PMID 39566128
- DERIVEDFernandes MFR, Bianchi-Ferraro AMHM, Sartori MGF, Jarmy Di Bella ZIK, Cantarelli GC, Dedonatto C, Vanzin RB, Dardes RCM, Logullo AF, Patriarca MT; LARF Study Group. CO 2 laser, radiofrequency, and promestriene in the treatment of genitourinary syndrome of menopause in breast cancer survivors: a histomorphometric evaluation of the vulvar vestibule. Menopause. 2023 Dec 1;30(12):1213-1220. doi: 10.1097/GME.0000000000002274. Epub 2023 Nov 14. PMID 37963315