Effects of Erbium-Yag Laser in Women With Genitourinary Syndrome of Menopause Undergoing Estrogen Therapy

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 26, 2025

Primary Completion Date

July 20, 2025

Study Completion Date

August 30, 2025

Conditions
Genitourinary Syndrome of Menopause
Interventions
DRUG

Topical estrogen therapy based on estriol (E3)

Patients will use low-dose isolated topical estrogen therapy in the form of estriol 1mg/g vaginal cream (Generic), with disposable, individualized vaginal applicators pre-set at the recommended dosage of 5g/dose each. Initially, they will use it for 14 consecutive nights, and then use it 2 times a week, always during the night, on Mondays and Thursdays, for 16 consecutive weeks from the start of the research. The treatment will be provided in fractions for each 30-day period and will always be delivered after each laser session, along with a leaflet containing usage, storage, and application instructions for the vaginal cream. The patients will be monitored through a messaging app, reinforcing the instructions and the days of application correctly.

RADIATION

Laser Er:YAG On

All participants in the group will undergo 3 applications of the Er:YAG laser with an interval of 4-5 weeks between them. The intimate laser session consists of 2 stages, using a PS03-fractional tip: the internal stage (vaginal canal) and the external stage (region of the vestibule and introitus).

RADIATION

Laser Er:YAG Off

All participants in the group will undergo 3 applications of the Er:YAG laser with the device turned off, with an interval of 4-5 weeks between them. The intimate laser session consists of 2 stages, using a PS03 fractional tip: the internal stage (vaginal canal) and the external stage (vestibule and introitus region).

All Listed Sponsors
lead

University of Nove de Julho

OTHER

NCT06873971 - Effects of Erbium-Yag Laser in Women With Genitourinary Syndrome of Menopause Undergoing Estrogen Therapy | Biotech Hunter | Biotech Hunter