NCT04902794

Light Emitting Diode in the Treatment of Genitourinary Syndrome of Menopause

Status unknown NA Last updated 23 June 2023

What this trial tests

NA trial testing Light Emitting Diode in Atrophy;Vaginal in 74 participants. Status unknown.

Timeline

1 December 2021

Primary endpoint
1 December 2022

1 December 2023

Quick facts

Lead sponsor	Patricia Lordelo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	1 December 2021
Primary completion	1 December 2022
Estimated completion	1 December 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Light Emitting Diode
• Sham Light Emitting Diode

Conditions studied

• Atrophy;Vaginal — all drugs for Atrophy;Vaginal →

Sponsor

Patricia Lordelo

Who can join

Adults 18 to 65, female only, with Atrophy;Vaginal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: The genitourinary menopause syndrome (MMS) affects 50% of postmenopausal women and, due to a decrease in hormone levels, triggers functional changes in the vagina and vagina, and impairment of quality of life and sexual function. Objective: To test the hypothesis that the 405 nm light emitting diode in the treatment of vulvovaginal atrophy is safe and effective, by reducing the symptomatology of the disease and histological alteration of the tissue. Methods: This is a pilot study in 10 volunteers with SGM, followed by a randomized, blinded trial in a sample of 58 individuals that will be performed at the Pelvic Floor Care Center (CAAP). Menopausal women up to 65 years of age and with clinical signs and symptoms of vulvovaginal atrophy syndrome (vaginal dryness and irritation, pruritus, pain or discomfort in intercourse, bleeding after sexual intercourse) and who voluntarily participate in the study will be included. Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, use of pacemaker, pregnant women, those who have performed Oophorectomy or presented ovarian cancer, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them. In the clinical trial, the study group will perform kinesiotherapy and LED.

The control group will perform kinesiotherapy and the LED will be turned off. Data collection will be performed initially and after the sessions through self-administered questionnaires containing socio-demographic and clinical information, Medical Outcomes Study 36, Short-Form Health Survey (SF-36), Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction. Expected results: The 405nm LED in the vaginal canal is expected to be safe and effective for SGM.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.