Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment

NACompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

October 25, 2018

Primary Completion Date

March 7, 2019

Study Completion Date

February 18, 2020

Conditions
Vaginal Atrophy
Interventions
DRUG

Promestriene Vaginal

Patients used promestriene vaginal cream for 3 months. The use was recommended to be diary fot the first 2 weeks, and then, repeat every 3 days.

OTHER

Fractional CO2 LASER

"LASER treatment with fractional CO2 Laser was performed in 3 sessions with intervals of 4 weeks between them. Before each session, the patients underwent specular examination.~Fractional CO2 LASER was applied following these parameters, fixed in all sessions: vagina wall - power40 W, dwel time 1000 mcs, spacing 1000 mcm and stack 2, vestibule - power 10W, dwel time 500mcs, spacing 300mcg and satck 1"

OTHER

Microablative Fractional radiofrequency

"Microablative fractional radiofrequency was performed with the equipment calibrated in FRAXX mode, 45W, Low Energy program 40 milliseconds in the vaginal and introitus wall. Lidocaine spray was applied to vaginal introitus before the procedure.~The patient was in the gynecological position. The vaginal speculum was placed and, afterwards, the vaginal antisepsis was performed with aqueous chlorhexidine and cleaning with 0.9% saline solution.~All liquid contents were wiped off before beginning the procedure. The fractured tip will be pressed lightly and as perpendicular as possible into the vulvar or vaginal surface, ensuring full contact of all points in the tissue, starting at the lateral vaginal walls and from the proximal to the distal third."

Trial Locations (1)

01246-100

Disciplina de ginecologia - departamento de ginecologia e obstetrícia - faculdade de medicina da USP, São Paulo

All Listed Sponsors
lead

University of Sao Paulo General Hospital

OTHER

NCT04717245 - Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment | Biotech Hunter | Biotech Hunter