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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vaginal Laxity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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