New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy

NATerminatedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

March 1, 2019

Primary Completion Date

December 8, 2021

Study Completion Date

December 8, 2021

Conditions
Vulvo-vaginal AtrophyGenitourinary Syndrome of Menopause
Interventions
DEVICE

Dynamic Quadripolar Radio-Frequency treatment

"Novel low-energy Dynamic Quadripolar Radio-frequency thermal treatment through Eva™ Device. Eva™ Device combines both advanced VDR™ technology (Vaginal Dynamic Radiofrequency) and RSS™ (Radiofrequency Safely System) technology."

DRUG

pH-Cream

1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)

Trial Locations (5)

Unknown

CHU Brugmann, Brussels

CHU Saint-Pierre, Brussels

Hôpital Erasme, Brussels

Hôpitaux Iris Sud, Brussels

Jules Institute Bordet, Brussels

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NOVAVISION GROUP S.P.A

UNKNOWN

collaborator

Jules Bordet Institute

OTHER

collaborator

Erasme University Hospital

OTHER

collaborator

Centre Hospitalier Universitaire Brugmann

OTHER

collaborator

Hôpitaux IRIS Sud

UNKNOWN

lead

Serge Rozenberg

OTHER