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Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy

NCT04607798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-10-29

No results posted yet for this study

Summary

The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of symptoms related to genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA). All subjects will receive a total of three internal treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.

Conditions

  • Genitourinary Syndrome of Menopause
  • Vulvovaginal Atrophy
  • Menopause

Interventions

DEVICE

Radiofrequency and pulsed electro-magnetic fields treatment

Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Matthew Gronski, PhD · Venus Concept

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT04607798 on ClinicalTrials.gov