Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Status:
Not yet recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
Menopause is a physiological event and is defined as the loss of ovarian follicular activity,
with consequent permanent cessation of menstrual cycles. Its diagnosis is made
retrospectively after 12 months of amenorrhea, with no pathological cause involved. This
period is marked by several changes in the female organism, mainly the genitourinary syndrome
(GUS), which is a collection of signs and symptoms resulting from the state of
hypoestrogenism. Almost half of postmenopausal women will experience symptoms of GUS, with
vaginal dryness being the most prevalent, followed by dyspareunia and vulvovaginal
irritation. The aim of the study is to evaluate the effect of photobiomodulation with red LED
(ligth emitting diode) on the symptoms of vulvovaginal atrophy in postmenopausal women. A
randomized and controlled clinical trial will be developed, which will include postmenopausal
women with signs and symptoms of vulvovaginal atrophy. Participants will be allocated into
two groups: those who will undergo photobiomodulation with intravaginal LED, and those who
will receive vaginal cream with estriol. Objective and subjective improvement of atrophy will
be assessed using the Vaginal Health Index and the visual analog scale, respectively. Vaginal
pH, cell maturation index and changes in sexual function through the Female Sexual Function
Index questionnaire will also be assessed. The variables will be analyzed at the time of
admission, in one and three months after the intervention.