Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy

NACompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 25, 2018

Primary Completion Date

September 30, 2022

Study Completion Date

December 31, 2022

Conditions
Vulvovaginal Atrophy
Interventions
DEVICE

Venus Fiore Study Treatment

Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes).

DEVICE

Venus Fiore Sham Treatment

Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes).

Trial Locations (2)

27100

IRCCS Policlinico S. Matteo, Pavia

28009

Institute Palacios, Madrid

All Listed Sponsors
lead

Venus Concept

INDUSTRY

NCT03725410 - Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy | Biotech Hunter | Biotech Hunter