Status:
NOT_YET_RECRUITING
Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
45-65 years
Brief Summary
Genitourinary Syndrome of Menopause (GSM), characterized by vaginal dryness, pain, urinary incontinence, and other symptoms, can be mitigated through both hormonal and non-hormonal treatments. Collage...
Detailed Description
Genitourinary Syndrome of Menopause (GSM) includes a variety of symptoms related to the decline of circulating ovarian hormones. The syndrome is characterized by complaints of vaginal dryness, dyspare...
Eligibility Criteria
Inclusion
- Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy)
- Patients with Genitourinary Syndrome and the presence of vulvovaginal atrophy/vestibular trophism alteration (defined as Vaginal Health Index - VHI - less than 15; and Vestibular Trophic Health Score - VeTH - more than 5) and/or initial urinary incontinence based on patient history (stress incontinence , urge incontinence, nicturia reported by patients,) positive IU tests (Stamey score 1: loss of urine with sudden increase in abdominal pressure such as from coughing, sneezing, or laughing) and on a standardized stress test provocation \[(cough test supine and in a standing position with a full bladder (300 ml)\] in healthy post-menopausal women and/or positive OABSS score for overactive bladder.
- Patients willing to provide Informed consent to participate in the study.
- Women aged between 45 and 65 years.
Exclusion
- Renal insufficiency or sever nephropathy.
- In case of known hypersensitivity to one or more of the components contained in the food supplement.
- Active or recent (30 days) genitourinary tract infection.
- Abnormal uterine bleeding.
- Use of lubricants or any other local or systemic preparations, within the 30 days prior to the study.
- Genital prolapse (grade II - III according to the Pelvic Organ Prolapse-Quantification, POP-Q, system classification).
- Serious or chronic condition that could interfere with study compliance.
- Treatment with hormones or other medicines to relieve menopausal symptoms within the 3 months prior the study.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT07151482
Start Date
September 1 2025
End Date
February 28 2028
Last Update
September 3 2025
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