NCT03857893

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

Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Serge Rozenberg · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Vulvo-Vaginal Atrophy (VVA) or Genitourinary Syndrome of Menopause (GSM) is a common and under-reported condition associated with decreased estrogenization of the vaginal tissue The aim of this study is to evaluate safety and efficacy of " Dynamic Quadripolar Radio-frequency" thermal treatment with Vaginal Dynamic Radio-frequency (VDR™) and Radio-frequency Safety System (RSS™) for the treatment of VVA and GSM in postmenopausal women who either present contra-indication for menopause hormone therapy, or are not willing to use Menopause Hormone Therapy (MHT) or have failed to be helped using MHT.

Conditions

• Vulvo-vaginal Atrophy
• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-03-01
• Primary completion: 2021-12-08
• Completion: 2021-12-08
• First posted: 2019-02-28
• Last updated: 2022-03-24

Locations

5 sites across 1 country: Belgium