LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)

NAActive, not recruitingINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Vaginal AtrophyVulva; AtrophyBreast Cancer
Interventions
PROCEDURE

LASER

The patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use.vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured.

PROCEDURE

Micro Ablative Radiofrequency

Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured

DRUG

Promestriene

The patient will perform self application of this vaginal promestriene daily for 2 weeks and after that the applications will occur twice a week.

Trial Locations (1)

0-4023- 062

Federal University of Sao Paulo - Unifesp, São Paulo

All Listed Sponsors
collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

lead

Federal University of São Paulo

OTHER