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 range
19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.