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Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.

NCT04487392 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-06-29

No results posted yet for this study

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.

Conditions

  • Vulvovaginal Atrophy

Interventions

DRUG

Estrogen vaginal cream group (group A)

The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home: 1 intravaginal applicator at night, daily for 2 weeks, followed by 2 times a week, on alternate days (Monday - Thursday) for another 2 weeks.

RADIATION

Photobiomodutation group (group B)

The participants selected for group B will be undergo photobiomodulation with red LED. With the participant in the lithotomy position, the speculum will be introduced into the vaginal canal and a vaginal wash with 0.9% saline will be performed to remove secretions. Afterwards, the speculum will be removed and the device with a red LED inserted up to about 6 cm from the introitus. A non-lubricated condom will be used in the LED device for patient protection. Sessions will take place once a week for 4 weeks.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2021-09-30
Completion
2021-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04487392 on ClinicalTrials.gov