Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy (NCT04607798) | Clinical Trial Compass
CompletedNot Applicable
Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy
Ukraine40 participantsStarted 2017-10-03
Plain-language 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.
Who can participate
Age range19 Years
SexFEMALE
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Inclusion criteria
✓. Healthy female subjects, ≥19 years of age presenting with symptoms associated with GSM/VVA.
✓. Requesting treatment for vulvovaginal tissue for improvement of symptoms associated with GSM/VVA, with a score of ˂26.55 on the FSFI.
✓. Sexual activity (vaginal intercourse minimum twice per month) in a monogamous relationship.
✓. At least one full-term pregnancy (\>36 weeks gestation) with vaginal delivery completed at least one year before study enrollment.
Exclusion criteria
✕. Pregnant or intending to become pregnant during the course of study.
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Having a permanent implant in the treated area (e.g. intrauterine device)
✕. Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treated area within 4-6 weeks of the initial treatment or during the course of the study.
✕. Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
✕. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
✕. Open laceration, abrasion, bleeding, infection or inflammation of any sort on or in the area to be treated.