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

NCT03857893 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-03-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • NOVAVISION GROUP S.P.A

    collaborator UNKNOWN

  • Jules Bordet Institute

    collaborator OTHER

  • Erasme University Hospital

    collaborator OTHER

  • Centre Hospitalier Universitaire Brugmann

    collaborator OTHER

  • Hôpitaux IRIS Sud

    collaborator UNKNOWN

  • Serge Rozenberg

    lead OTHER

Principal Investigators

  • Serge Rozenberg, MD,PhD · Centre Hospitalier Universitaire Saint Pierre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-12-08
Completion
2021-12-08

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857893 on ClinicalTrials.gov