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Radiofrequency and Pulsed Electromagnetic Field Energies

Vulvovaginal treatment for Menopause

N/A
Waitlist Available
Research Sponsored by Venus Concept
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights

Study Summary

The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the mons pubis and labia for skin tightening. All subjects will receive a total of three internal and three external treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.

Eligible Conditions
  • Menopause
  • Vulvovaginal Atrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaginal Laxity

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vulvovaginal treatmentExperimental Treatment2 Interventions
Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments.
Group II: BaselineActive Control1 Intervention
Subject's baseline photograph to act as their own control for the one-month and four-month post-treatment photograph of the mons pubis and labia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vulvovaginal treatment
2018
N/A
~70
Baseline
2007
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,305 Total Patients Enrolled
2 Trials studying Menopause
50 Patients Enrolled for Menopause
Paul CardarelliStudy DirectorVenus Concept
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
2018. "Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03536585.
~9 spots leftby Apr 2025
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