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Sponsor study identifier
interventional
74
1 country
1
Study Start
December 1, 2021
Actual (reported)Primary Completion
December 1, 2022
Actual (reported)Study Completion
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2021
Actual (reported)May 26, 2021
Actual (reported)December 1, 2021
Actual (reported)December 1, 2022
Actual (reported)December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Vaginal maturation index
Cytological vaginal will be collected at one third lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Change from baseline at 3 months
Female Sexual Function Index (FSFI) - Female Version (QS-F)
Measure of quality of sex life. Full Scale Score Range 2-36 - The higher final score, better is the sexual function
Change from baseline at 3 months
Vaginal pH
Change from baseline at 3 months
Urinary symptoms
Change from baseline at 3 months
Visual analog scale
Change from baseline at 3 months
Female Genital Self-Image Scale - 7 (FGSIS-7)
Change from baseline at 3 months]
Likert scale
Change from finished treatment and 3 months after
Light Emitting Diode in the Treatment of Menopause Genitourinary Syndrome
Light Emitting Diode device Sham - turned off
Blue light-emitting diode applied to the female genital region for eight minutes, for five sessions, one per week
Sham Blue light-emitting diode turned off applied to the female genital region for eight minutes, for five sessions, one per week
Instituto Patrícia Lordelo
Salvador, Estado de Bahia, 41825-000, Brazil
First Submitted
May 20, 2021
First Posted
May 26, 2021
Study Start
December 1, 2021
Actual (reported)Primary Completion
December 1, 2022
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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