drugset / Trial / NCT04081805
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
Active not recruiting
195 enrolled
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2019-09-30
- Primary completion
- 2025-09
- Completion
- 2025-09
Publications
- Cantarelli 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.
- Fernandes 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Promestriene | Other / unclassified | — | Intrathecal |