Status:
TERMINATED
New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
Lead Sponsor:
Serge Rozenberg
Collaborating Sponsors:
NOVAVISION GROUP S.P.A
Jules Bordet Institute
Conditions:
Vulvo-vaginal Atrophy
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
40-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03857893
Start Date
March 1 2019
End Date
December 8 2021
Last Update
March 24 2022
Active Locations (5)
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1
CHU Brugmann
Brussels, Belgium
2
CHU Saint-Pierre
Brussels, Belgium
3
Hôpital Erasme
Brussels, Belgium
4
Hôpitaux Iris Sud
Brussels, Belgium