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

NCT03857893 | Terminated

• 1 other identifier: B076201938646
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Vulvo-vaginal Atrophy; Genitourinary Syndrome of Menopause

Keywords

Vulvo-vaginal atrophy; Dynamic Quadripolar Radio-Frequency; Menopause; Genitourinary syndrome of menopause

Outcome Measures

Primary Outcomes (3)

• 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).

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

• 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.

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

• 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)

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

Secondary Outcomes (3)

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

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

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

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

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

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

Study Arms (2)

Control Group : pH-Cream

ACTIVE COMPARATOR

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).

Drug: pH-Cream

Dynamic Quadripolar Radio-Frequency treatment

EXPERIMENTAL

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.

Device: Dynamic Quadripolar Radio-Frequency treatment; Drug: pH-Cream

Interventions

Dynamic Quadripolar Radio-Frequency treatment DEVICE

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.

Dynamic Quadripolar Radio-Frequency treatment

pH-Cream DRUG

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

Also known as: Cetomacrogol cream

Control Group : pH-Cream; Dynamic Quadripolar Radio-Frequency treatment

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Serge Rozenberg: lead
• NOVAVISION GROUP S.P.A: collaborator
• Jules Bordet Institute: collaborator
• Erasme University Hospital: collaborator
• Centre Hospitalier Universitaire Brugmann: collaborator
• Hôpitaux IRIS Sud: collaborator

Study Sites (5)

CHU Brugmann

Brussels, Belgium

Location

CHU Saint-Pierre

Brussels, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

Hôpitaux Iris Sud

Brussels, Belgium

Location

Jules Institute Bordet

Brussels, Belgium

Location

Related Publications (17)

• 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.

  PMID: 10782451 BACKGROUND

• 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.

  PMID: 23481118 BACKGROUND

• 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.

  PMID: 26725467 BACKGROUND

• 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.

  PMID: 28608667 BACKGROUND

• 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.

  PMID: 23419265 BACKGROUND

• 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.

  PMID: 20828948 BACKGROUND

• 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.

  PMID: 27832260 BACKGROUND

• 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.

  PMID: 23679050 BACKGROUND

• 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.

  PMID: 16443612 BACKGROUND

• 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.

  PMID: 26323234 BACKGROUND

• 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.

  PMID: 22990756 BACKGROUND

• 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.

  PMID: 18645698 BACKGROUND

• 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.

  PMID: 17364601 BACKGROUND

• 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.

  PMID: 25156453 BACKGROUND

• 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.

  PMID: 23984673 BACKGROUND

• 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.

  PMID: 19351658 BACKGROUND

• 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.

  PMID: 38251861 DERIVED

Study Officials

• Serge Rozenberg, MD,PhD

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Gynecology Department

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: March 1, 2019
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (5)