Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients (NCT07151482) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients
43 participantsStarted 2025-09-01
Plain-language 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. Collagen peptides have shown promising results in improving skin, cartilage, and exhibiting antioxidative activities in studies. This study evaluates changes of quality of life and sexual function, related to vulvovaginal atrophy (VVA) and initial urinary incontinence (UI) in women with GSM symptoms, with the intake of a daily oral food supplement containing 2.5 g of Bioactive Collagen Peptides (BCP®) and other functional ingredients over a 16-week period . This can represent a new therapeutic option for these patients, particularly when hormonal therapy is not an option.
Who can participate
Age range45 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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.
* Trea…