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Device

Vulvovaginal Treatment for Vulvovaginal Atrophy

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 12 months
Awards & highlights

Study Summary

This trial is testing whether a 12-month extension of a previous study of Multi-Polar RF and PEMF technologies can improve vaginal laxity and skin laxity around the mons pubis and labia. Up to 50 subjects who completed the previous study will be enrolled, and followed up for at least 6 and 12 months post-treatment.

Eligible Conditions
  • Vulvovaginal Atrophy
  • Menopause

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Long term safety (Follow-up for any AEs) of the Venus Fiore Fiore™ (MP)2 system in vaginal laxity and skin laxity of the mons pubis and labia.
Secondary outcome measures
long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vulvovaginal TreatmentExperimental Treatment1 Intervention
At visit 1 -(6 months post treatment in the CS0716 study): AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), At Visit 2 (6 months post treatment in the CS0716 study): AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), Administer study treatment (optional: internal, mons pubis and/or labia treatment). Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided) Final AE follow-up 30 days post Visit 2 Treatment (if applicable): AE assessment (applicable only if treatment provided at Visit 2 in the FE1019 study).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vulvovaginal Treatment
2019
N/A
~10

Find a Location

Who is running the clinical trial?

Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,332 Total Patients Enrolled
Mathew GronskiStudy DirectorVenus Concept

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
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
2019. "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/NCT04210583.
~2 spots leftby Apr 2025
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