TerminatedNot Applicable

New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy

Stopped: The study was delayed due to the Covid 19 pandemic. The study was stopped prematurely due to a lack of efficiency (reported by the patients)

Belgium53 participantsStarted 2019-03-01

Plain-language summary

Vulvo-Vaginal Atrophy (VVA) or Genitourinary Syndrome of Menopause (GSM) is a common and under-reported condition associated with decreased estrogenization of the vaginal tissue The aim of this study is to evaluate safety and efficacy of " Dynamic Quadripolar Radio-frequency" thermal treatment with Vaginal Dynamic Radio-frequency (VDR™) and Radio-frequency Safety System (RSS™) for the treatment of VVA and GSM in postmenopausal women who either present contra-indication for menopause hormone therapy, or are not willing to use Menopause Hormone Therapy (MHT) or have failed to be helped using MHT.

Who can participate

Age range

40 Years – 75 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

. Vaginal dryness (none, mild, moderate or severe),
. Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
. Vaginal pain associated with sexual activity (none, mild, moderate or severe)
. A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
. A vaginal pH \> 5

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.

What they're measuring

Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire

Timeframe: Up to 12 (+4 weeks) week after beginning of treatment

Change from baseline to week 12 (+4 weeks) of vaginal cell maturation (Maturation Index).

Timeframe: Up to 12 (+4 weeks) week after beginning of treatment

Change from baseline to week 12 (+4 weeks) of vaginal pH

Timeframe: Up to 12 (+4 weeks) week after beginning of treatment

Trial details

NCT IDNCT03857893

SponsorSerge Rozenberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-08

View on ClinicalTrials.gov More Vulvo-vaginal Atrophy trials

Plain-language summary

Who can participate

Age range

40 Years – 75 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

. Vaginal dryness (none, mild, moderate or severe),
. Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
. Vaginal pain associated with sexual activity (none, mild, moderate or severe)
. A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
. A vaginal pH \> 5

What they're measuring

Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire

Timeframe: Up to 12 (+4 weeks) week after beginning of treatment

Change from baseline to week 12 (+4 weeks) of vaginal cell maturation (Maturation Index).

Timeframe: Up to 12 (+4 weeks) week after beginning of treatment

Change from baseline to week 12 (+4 weeks) of vaginal pH

Timeframe: Up to 12 (+4 weeks) week after beginning of treatment