LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
195 patients around the world
Available in Brazil
Women treated for breast cancer with moderate or severe signs or symptoms of vulvovaginal
atrophy will be eligible for the study.
The patients will be randomized to receive one of the three intravaginal therapies: LASER,
Micro Ablative radiofrequency or Promestriene. The applications will occur in the interval of
30 days for 3 times, for LASER and Radiofrequency groups. For the promestriene group, the
application will be done by the patient, daily for 2 weeks and then twice a week for 3
months, and each 30 days, the patients will have an appointment when will be checked the
weight of the promestriene tube, to verify the correct use.
The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third
month of treatment.
Will be evaluated: vulvar and vaginal histology before and after the use of LASER,
radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER,
radiofrequency or promestriene; extracellular matrix and metalloproteinases in the remodeling
of vulvovaginal collagen induced by promestriene, LASER and radiofrequency; quality of life,
sexual dysfunctions and complains before and after the use of LASER, radiofrequency or
hormones; metabolomics and vaginal microbiome.