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ACTIVE NOT RECRUITING
NCT04081805
NA

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

Sponsor: Federal University of São Paulo

View on ClinicalTrials.gov

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.

Official title: LASER and Radiofrequency as Alternative Treatment of Vaginal Vulvar Atrophy in Women Treated for Breast Cancer

Key Details

Gender

FEMALE

Age Range

30 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2019-09-30

Completion Date

2025-09

Last Updated

2025-04-24

Healthy Volunteers

No

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.

Locations (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, Brazil