New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
NCT ID: NCT03857893
Last Updated: 2022-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
53 participants
INTERVENTIONAL
2019-03-01
2021-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Group : pH-Cream
Control 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).
pH-Cream
1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
Dynamic Quadripolar Radio-Frequency treatment
Experimental 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.
Dynamic Quadripolar Radio-Frequency treatment
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-Cream
1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
Interventions
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Dynamic Quadripolar Radio-Frequency treatment
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-Cream
1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Vaginal dryness (none, mild, moderate or severe),
2. Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
3. Vaginal pain associated with sexual activity (none, mild, moderate or severe)
* Postmenopausal women with VVA confirmed by at least one of the following criteria:
1. A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
2. 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.
Exclusion Criteria
* 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.
* 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
40 Years
75 Years
FEMALE
No
Sponsors
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NOVAVISION GROUP S.P.A
UNKNOWN
Jules Bordet Institute
OTHER
Erasme University Hospital
OTHER
Centre Hospitalier Universitaire Brugmann
OTHER
Hôpitaux IRIS Sud
UNKNOWN
Serge Rozenberg
OTHER
Responsible Party
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Serge Rozenberg
Head of Gynecology Department
Principal Investigators
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Serge Rozenberg, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Saint Pierre
Locations
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CHU Brugmann
Brussels, , Belgium
CHU Saint-Pierre
Brussels, , Belgium
Hôpital Erasme
Brussels, , Belgium
Hôpitaux Iris Sud
Brussels, , Belgium
Jules Institute Bordet
Brussels, , Belgium
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Rozenberg S, Pornel B, Koninckx PR, Palacios S, Christiansen C. Endometrium protection and acceptability of nasally administered continuously combined hormone therapy: a multicentre, multinational, double-blind trial in post-menopausal women evaluating three regimens of 17beta-estradiol and norethisterone when compared with an orally administered 17beta-estradiol norethisterone regimen. Hum Reprod. 2009 Jul;24(7):1739-47. doi: 10.1093/humrep/dep067. Epub 2009 Apr 7.
Joris A, Di Pietrantonio V, Praet J, Renard K, Verduyn AC, Buxant F, Rozenberg S. Randomized trial: treatment of genitourinary syndrome of menopause using radiofrequency. Climacteric. 2024 Apr;27(2):210-214. doi: 10.1080/13697137.2024.2302425. Epub 2024 Jan 22.
Other Identifiers
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B076201938646
Identifier Type: -
Identifier Source: org_study_id
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