[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604589":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":19,"locations":7,"responsibleParty":24,"collaborators":7,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":32,"eligibilityCriteria":33,"healthyVolunteers":28,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":7,"studyType":40,"phases":7,"briefSummary":41,"conditions":42,"keywords":7,"overallStatus":44,"whyStopped":7,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":7},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DIETARY_SUPPLEMENT","Collagendep","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.",[14],"QOL questionnaires",[16],{"name":17,"affiliation":5,"role":18},"Paola Villa","PRINCIPAL_INVESTIGATOR",[20],{"name":17,"role":21,"phone":22,"phoneExt":7,"email":23},"CONTACT","+39 3392318208","paola.villa@policlinicogemelli.it",{"type":25,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100604589","impact-of-oral-supplementation-with-bioactive-collagen-peptides-and-other-functional-ingredients-100604589",false,"NCT07151482","Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients","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)","Maicol","Inclusion Criteria:\n\n* Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy)\n* Patients with Genitourinary Syndrome and the presence of vulvovaginal atrophy\u002Fvestibular trophism alteration (defined as Vaginal Health Index - VHI - less than 15; and Vestibular Trophic Health Score - VeTH - more than 5) and\u002For 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\u002For positive OABSS score for overactive bladder.\n* Patients willing to provide Informed consent to participate in the study.\n* Women aged between 45 and 65 years.\n\nExclusion Criteria:\n\n* Renal insufficiency or sever nephropathy.\n* In case of known hypersensitivity to one or more of the components contained in the food supplement.\n* Active or recent (30 days) genitourinary tract infection.\n* Abnormal uterine bleeding.\n* Use of lubricants or any other local or systemic preparations, within the 30 days prior to the study.\n* Genital prolapse (grade II - III according to the Pelvic Organ Prolapse-Quantification, POP-Q, system classification).\n* Serious or chronic condition that could interfere with study compliance.\n* Treatment with hormones or other medicines to relieve menopausal symptoms within the 3 months prior the study.","FEMALE","45 Years","65 Years",{"count":38,"type":39},43,"ESTIMATED","OBSERVATIONAL","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.",[43],"Genitourinary Syndrome of Menopause","NOT_YET_RECRUITING","2025-08-25",{"date":47,"type":48},"2025-09-03","ACTUAL",{"date":50,"type":39},"2025-09-01",{"date":52,"type":39},"2028-02-28",{"name":5,"class":6}]