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Vulvo-vaginal AtrophyViViANCT03857893

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

A study testing Dynamic Quadripolar Radio-Frequency treatment and pH-Cream in people with Vulvo-vaginal Atrophy and Genitourinary Syndrome of Menopause, run by Serge Rozenberg at 5 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years, women only
What is being tested?
Dynamic Quadripolar Radio-Frequency treatment and pH-Cream
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
5 sitesBelgium
Study dates
1 Mar 2019to 8 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women suffering of Vulvo-Vaginal atrophy (VVA), included Breast Cancer survivors defined as having self-identified at least one mild to severe of the following symptoms:
  • 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)
  • Postmenopausal women with VVA confirmed by at least one of the following criteria:
  • A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
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  • A vaginal pH > 5
  • Postmenopausal women between 40 and 75 years of age (non hysterectomized or hysterectomized). Menopause will be assessed either by amenorrhea of > 1 year and / or by Follicle Stimulating Hormone (FSH) > 30 UI/L and estradiol (E2) < 20 pg/ml
  • They must have either a contraindication to hormonal therapies, a failure of previous use of hormonal therapies (either systemic and/or local) or must have refused to take hormonal therapy.
  • Willing to participate in the study and sign an informed consent.

Who cannot join

  • Undiagnosed abnormal genital bleeding.
  • The administration of any investigational drug within 30 days of screening visit.
  • Endometrial hyperplasia at biopsy performed at screening or endometrial cancer.
  • Use of estrogens/progestins products (vaginal, oral, pellet, transdermal....) in the 4 weeks to months (depending on the product used) prior study entry.
  • Presence of severe medical disease or neurological disease or important co-morbidities.
  • Other gynaecological malignancies.
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  • Recent vaginal surgery .
  • A clinically relevant prolapse (Pelvic Organ Prolapse-Quantification System (POP-Q) ≤ 2)
  • Current urinary tract or vaginal infection or recent sexually transmitted disease
  • Anticoagulant treatment
  • People with pacemakers and/or other implanted electrodes (Intra-Uterine Device (IUD) and surgical pelvic implants for sterilization are not considered as contraindication)
  • Disabled people unable to communicate

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites

  • CHU Brugmann

    Brussels

  • CHU Saint-Pierre

    Brussels

  • Hôpital Erasme

    Brussels

  • Hôpitaux Iris Sud

    Brussels

  • Jules Institute Bordet

    Brussels

Other trials in Belgium

About this study

Official title: Thermal Treatment of Vulvo-vaginal Atrophy (VVA) Using Novel Low-energy Dynamic Quadripolar Radio-Frequency (DQRF)

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.

Being tested
Dynamic Quadripolar Radio-Frequency treatment, pH-Cream
Keywords
Vulvo-vaginal atrophy, Dynamic Quadripolar Radio-Frequency, Menopause, Genitourinary syndrome of menopause

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Quadripolar Radio-Frequency treatmentDevice

    Novel low-energy "Dynamic Quadripolar Radio-frequency" thermal treatment through Eva™ Device. Eva™ Device combines both advanced VDR™ technology (Vaginal Dynamic Radiofrequency) and RSS™ (Radiofrequency Safely System) technology.

  • pH-CreamDrug

    Also called Cetomacrogol cream

    1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)

Study groups in NCT03857893
Study groupRoleWhat they receive
Control Group : pH-CreamActive comparatorControl Group will be only treated with a fixed amount (1g) of pH-cream (Cetomacrogol cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days and if deem necessary, additional doses can be applied and notified in the calendar provided).
Receives: Drug: pH-Cream
Dynamic Quadripolar Radio-Frequency treatmentExperimentalExperimental Group will be treated with Dynamic Quadripolar Radio-Frequency (DQRF) (with Eva™ Device) for 8 weeks (+ 4 weeks). The Dynamic Quadripolar Radio-frequency sessions will involve -5 sessions (one every 14-21 days), if necessary External treatment (vulvar - will be applied before internal treatment for more comfort) : 10 minutes (5 minutes left side, 5 minutes right side), and Internal treatment (VVA, Vaginal Laxity, Mild-Stress Urinary Incontinence (SUI)): 20 minutes. In parallel, patients can also apply pH-cream (Cetomacrogol cream) (one dose of 1g) if they judge necessary but they are not allowed to use it during the seven days before radiofrequency session. If they use pH-cream, they must notify it in the calendar provided.
Receives: Device: Dynamic Quadripolar Radio-Frequency treatment; Drug: pH-Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The severity of dyspareunia recorded as none, mild, moderate or severe (score values of 0, 1, 2 or 3, respectively). Data obtained at baseline and week 12 (+4 weeks).

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

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

    The percentage of parabasal, superficial, intermediate cells will be determined from the vaginal smears collected during the study at baseline and week 12 (+4 weeks). The maturation index is the proportion of these 3 types of cells in each 100 cells counted on a smear.

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

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

    A pH strip will be applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip will be compared to the color chart for pH evaluation.Data obtained at baseline and week 12 (+4 weeks)

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

Secondary outcomes (3)

  1. Change from baseline to week 12 (+4 weeks) of the "Vaginal Health Index" (VHI)

    Evaluation of each of the four following signs of atrophy, which constitute together the Vaginal Health Index" (VHI). Vaginal Secretions, Vaginal Epithelial Integrity, Vaginal Epithelial Surface Thickness, Vaginal Color will be evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy and will be analyzed using the score values of 1, 2, 3 and 4, respectively. The visual evaluation of the vagina (petechiae, pallor, friability and dryness or redness in vaginal mucosa) will be assessed using the pictures by the physician blinded to the treatment. Data will be obtained at baseline and week 12 (+4 weeks).

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

  2. Change from baseline to week 12 (+4 weeks) of the vulvovaginal symptoms

    The vulvovaginal symptoms will be evaluated by a 'vulvovaginal symptoms questionnaire" in postmenopausal women at baseline and week 12 (+4 weeks).

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

  3. Change from baseline to week 12 (+4 weeks) in the two groups of the "Female Sexual Function Index (FSFI)

    The Female Sexual Function Index is measured by a questionnaire evaluating self-reported sexual functioning during the previous month. This includes 19 items grouped within six central domains: desire (items 1 and 2), arousal (items 3 to 6), lubrication (items 7 to 10), orgasm (items 11 to 13), global sexual and relationship satisfaction (items 14 to 16), and pain (items 17 to 19). Each domain was scored on a scale of 0 to 6 with lower scores indicating lower sexual functioning. A domain score of 0 indicated that the women reported no sexual activity. The individual domain scores were then totaled and multiplied by a predetermined factor to weight each domain equally.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2019
  2. Study start1 Mar 2019
  3. Primary completion8 Dec 2021
  4. Study completion8 Dec 2021

Why it 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)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03857893
Sponsor's protocol ID
B076201938646
Acronym
ViViA
Status last verified
Mar 2022
First submitted
26 Feb 2019
Last updated
24 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data will be shared and will be available on a website at the end of the study. The website where the data will be hosted, has not been yet decided.

Publications

  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

    PubMed 10782451

  • Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, Kenton KS, Fried TR. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause. 2013 Sep;20(9):973-9. doi: 10.1097/GME.0b013e318282600b.

    PubMed 23481118

  • Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.

    PubMed 26725467

  • Vicariotto F, DE Seta F, Faoro V, Raichi M. Dynamic quadripolar radiofrequency treatment of vaginal laxity/menopausal vulvo-vaginal atrophy: 12-month efficacy and safety. Minerva Ginecol. 2017 Aug;69(4):342-349. doi: 10.23736/S0026-4784.17.04072-2.

    PubMed 28608667

  • Rozenberg S, Vandromme J, Antoine C. Postmenopausal hormone therapy: risks and benefits. Nat Rev Endocrinol. 2013 Apr;9(4):216-27. doi: 10.1038/nrendo.2013.17. Epub 2013 Feb 19.

    PubMed 23419265

  • Nappi RE, Kokot-Kierepa M. Women's voices in the menopause: results from an international survey on vaginal atrophy. Maturitas. 2010 Nov;67(3):233-8. doi: 10.1016/j.maturitas.2010.08.001. Epub 2010 Sep 9.

    PubMed 20828948

  • Melisko ME, Goldman ME, Hwang J, De Luca A, Fang S, Esserman LJ, Chien AJ, Park JW, Rugo HS. Vaginal Testosterone Cream vs Estradiol Vaginal Ring for Vaginal Dryness or Decreased Libido in Women Receiving Aromatase Inhibitors for Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2017 Mar 1;3(3):313-319. doi: 10.1001/jamaoncol.2016.3904.

    PubMed 27832260

  • Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16.

    PubMed 23679050

  • Kendall A, Dowsett M, Folkerd E, Smith I. Caution: Vaginal estradiol appears to be contraindicated in postmenopausal women on adjuvant aromatase inhibitors. Ann Oncol. 2006 Apr;17(4):584-7. doi: 10.1093/annonc/mdj127. Epub 2006 Jan 27.

    PubMed 16443612

  • Hutchinson-Colas J, Segal S. Genitourinary syndrome of menopause and the use of laser therapy. Maturitas. 2015 Dec;82(4):342-5. doi: 10.1016/j.maturitas.2015.08.001. Epub 2015 Aug 12.

    PubMed 26323234

  • Baumgart J, Nilsson K, Evers AS, Kallak TK, Poromaa IS. Sexual dysfunction in women on adjuvant endocrine therapy after breast cancer. Menopause. 2013 Feb;20(2):162-8. doi: 10.1097/gme.0b013e31826560da.

    PubMed 22990756

  • Antoine C, Vandromme J, Fastrez M, Carly B, Liebens F, Rozenberg S. A survey among breast cancer survivors: treatment of the climacteric after breast cancer. Climacteric. 2008 Aug;11(4):322-8. doi: 10.1080/13697130802244422.

    PubMed 18645698

  • Antoine C, Liebens F, Carly B, Pastijn A, Rozenberg S. Safety of alternative treatments for menopausal symptoms after breast cancer: a qualitative systematic review. Climacteric. 2007 Feb;10(1):23-6. doi: 10.1080/13697130601176734.

    PubMed 17364601

  • Ameye L, Antoine C, Paesmans M, de Azambuja E, Rozenberg S. Menopausal hormone therapy use in 17 European countries during the last decade. Maturitas. 2014 Nov;79(3):287-91. doi: 10.1016/j.maturitas.2014.07.002. Epub 2014 Aug 4.

    PubMed 25156453

  • Goldstein SR, Bachmann GA, Koninckx PR, Lin VH, Portman DJ, Ylikorkala O; Ospemifene Study Group. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric. 2014 Apr;17(2):173-82. doi: 10.3109/13697137.2013.834493. Epub 2013 Nov 23.

    PubMed 23984673

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Quadripolar Radio-Frequency treatment and pH-Cream in people with Vulvo-vaginal Atrophy and Genitourinary Syndrome of Menopause, run by Serge Rozenberg at 5 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to week 12 (+4 weeks) of self-assessment of the most bothersome symptom dyspareunia, evaluated by a questionnaire (time frame: Up to 12 (+4 weeks) week after beginning of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857893, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.

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