Clinical trial NCT04487392: Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Official title: Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Vulvovaginal Atrophy
Keywords: genitourinary syndrome
LED
light emitting diode
vulvovaginal atrophy
menopause
climacteric
photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women (amenorrhea for less than 12 months);
* presence one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation and vaginal burning);
* Vaginal Heath Index ≤ 15 (signs of atrophy);
* normal cytopathology of uterine cervix in the last year.

Exclusion Criteria:

* previous or current history of gynecological neoplasia;
* who used hormonal or non-hormonal treatment for vulvovaginal symptoms of menopause;
* current or recent genitourinary lesions or infectious processes in the genitourinary tract (last month);
* current or recent (last month) systemic treatment with antifungals, antibiotics or corticosteroids;
* presence of genital prolapse;
* presence of contraindications to the use of vaginal estrogen (current, previous or suspected diagnosis of breast cancer, malignant estrogen-dependent tumors, uninvestigated uterine bleeding, untreated endometrial hyperplasia, deep venous thrombosis and current or previous pulmonary thromboembolism, known thrombophilia, recent or active arterial disease, acute liver disease, porphyria, use of drugs that may interact with estriol and hypersensitivity to the components of the vaginal cream formula).

Primary outcomes:
measure: Objective assessment of improvement in vulvovaginal atrophy symptoms.
timeFrame: 6 months
measure: Subjetive assessment of improvement in vulvovaginal atrophy symptoms.
timeFrame: 6 months
Secondary outcomes:
measure: Vaginal pH
timeFrame: 6 months
measure: Female Sexual Function Index
timeFrame: 6 months
measure: Vaginal Cell Maturation Index
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, Santoro N, Simoncini T. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. doi: 10.1038/nrdp.2015.4.
citation: Schoenaker DA, Jackson CA, Rowlands JV, Mishra GD. Socioeconomic position, lifestyle factors and age at natural menopause: a systematic review and meta-analyses of studies across six continents. Int J Epidemiol. 2014 Oct;43(5):1542-62. doi: 10.1093/ije/dyu094. Epub 2014 Apr 26.
citation: Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
citation: Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
citation: Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16.
citation: Pacagnella Rde C, Martinez EZ, Vieira EM. [Construct validity of a Portuguese version of the Female Sexual Function Index]. Cad Saude Publica. 2009 Nov;25(11):2333-44. doi: 10.1590/s0102-311x2009001100004. Portuguese.