NCT04487392

Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.

Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-09-30
• Completion: 2021-12-30
• First posted: 2020-07-27
• Last updated: 2023-06-29