Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients

NCT07151482 | Not Yet Recruiting

• 1 other identifier: 7441
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

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. 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.

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (2)

• Quality of life in patient with GSM

  Evaluate the improvement of quality of life in relation to genitourinary symptoms, to evaluate acceptability and satisfaction with the use of collagen oral supplement in the treatment of Genitourinary Syndrome of Menopause (GSM). Quality of life will be evaluate through: QUOL questionnaire SF-12 (during visit T0 and T3). It's a 12-item questionnaire used to assess generic health outcomes from the patient's perspective like: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.

  24 weeks

• Sexual function in patient with GSM

  Evaluate the improvement of sexual function in relation to genitourinary symptoms, to evaluate acceptability and satisfaction with the use of collagen oral supplement in the treatment of Genitourinary Syndrome of Menopause (GSM) with: \- Female Sexual Function Index (FSFI - short form). FSFI has 19-item and includes: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), and pain (3 items). The score scale range is from 0 (worse) to 30 (better score)

  24 weeks

Secondary Outcomes (2)

• Evaluation of vaginal symptoms (included in genitourinary symptoms)

  24 weeks

• Evaluation of urinary symptoms (included in genitourinary symptoms)

  24 weeks

Interventions

Collagendep DIETARY_SUPPLEMENT

The purpose of this study is to evaluate the improvement of quality of life, vulvovaginal atrophy (VVA) and of initial Urinary Incontinence (UI) in menopausal women with GSM symptoms following oral administration of a food supplement treatment containing 2.5 g of BCP® and other functional ingredients taken once daily over a period of 16 weeks.

Also known as: QOL questionnaires

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy). Patients with Genitourinary Syndrome in particular suffering of vaginal dryness and/or urinary incontinence.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Officials

• Paola Villa

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Villa

CONTACT

+39 3392318208; paola.villa@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-07