Genitourinary Syndrome of MenopauseMaicolNCT07151482
Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients
An observational study of Genitourinary Syndrome of Menopause, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Collagendep
- Type of treatment
- Pill or oral medicine
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients on Quality of Life, Related to Vaginal Atrophy and Urinary Incontinence Inwomen With Genitourinary Syndrome of Menopause (GSM)
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.
Read the 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, dyspareunia, pain, urinary incontinence, and recurrent urinary tract infections.
Collagen hydrolysate (CH) has been used in pharmaceuticals and food supplements for improving skin and cartilage tissues. It is absorbed in the digestive tract, appears in the human blood partly in a small peptide form. Based on in vitro studies, collagen peptides (CPs) have shown to exert potent antioxidative activities in different oxidative systems.
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. The improvement of systemic health state and satisfaction with this supplement will be evaluated using both subjective and objective measures.
The aim is also to identify significant improvement in quality of sexual function and health of genitourinary system.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Collagendep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagendepDietary supplement
Also called QOL questionnaires
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 24 weeks
Secondary outcomes (2)
Evaluation of vaginal symptoms (included in genitourinary symptoms)
Evaluation of genitourinary symptoms (which include both vaginal symptoms and urinary incontinence symptoms).
vaginal symptoms will be performed using the following tool:
- Visual Analog Scale (VAS) for the severity of atrophy symptoms (pain, dryness, irritation and leucorrhea), score 0 (better) - 10 (worse).
Measured: 24 weeks
Evaluation of urinary symptoms (included in genitourinary symptoms)
Evaluation of genitourinary symptoms (which include both vaginal symptoms and urinary incontinence symptoms).
urinary symptoms will be performed using the following tool:
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) where maximum score of 21 represents permanent incontinence.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Villa, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151482
- Sponsor's protocol ID
- 7441
- Acronym
- Maicol
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients on Quality of Life, Related to Vaginal Atrophy and Urinary Incontinence Inwomen With Genitourinary Syndrome of Menopause (GSM)
- ClinicalTrials.gov ID
- NCT07151482
- Acronym / sponsor ID
- Maicol / 7441
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, dyspareunia, pain, urinary incontinence, and recurrent urinary tract infections.
Collagen hydrolysate (CH) has been used in pharmaceuticals and food supplements for improving skin and cartilage tissues. It is absorbed in the digestive tract, appears in the human blood partly in a small peptide form. Based on in vitro studies, collagen peptides (CPs) have shown to exert potent antioxidative activities in different oxidative systems.
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. The improvement of systemic health state and satisfaction with this supplement will be evaluated using both subjective and objective measures.
The aim is also to identify significant improvement in quality of sexual function and health of genitourinary system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CollagendepAlso: QOL questionnairesThe 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. | Dietary supplement | – |
Primary outcome
Quality of life in patient with GSM
Time frame: 24 weeks
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.
Sexual function in patient with GSM
Time frame: 24 weeks
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)
2 secondary outcomes
Evaluation of vaginal symptoms (included in genitourinary symptoms)
Time frame: 24 weeks
Evaluation of urinary symptoms (included in genitourinary symptoms)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola Villa principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Genitourinary Syndrome of Menopause, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Villa (+39 3392318208, paola.villa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in patient with GSM (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.