[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583716":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":11,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid","EXPERIMENTAL",null,[13],"Device: High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid",{"label":15,"type":16,"description":11,"interventionNames":17},"Hyaluronic acid-based gel (Hydeal-D®) applied once every three days","ACTIVE_COMPARATOR",[18],"Device: hyaluronic acid-based gel (Hydeal-D®)",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","five treatment sessions of high-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid 2 weeks apart with a duration of approximately 15 minutes",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"hyaluronic acid-based gel (Hydeal-D®)","hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Rossella Nappi, MD","CONTACT","+390382503325","r.nappi@smatteo.pv.it",[35],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita","RECRUITING","Pavia","27100","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],9.15917,45.19205,{"lat":46,"lon":45},[49],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Rossella Nappi","MD","100583716","concomitant-treatment-with-topical-hyaluronic-acid-and-high-concentration-oxygen-therapy-vaginal-natural-oxygenation-device---vnod-in-the-improvement-of-symptoms-related-to-genitourinary-syndrome-of-menopause-in-women-with-natural-and-oncological-postmenopause-open-label-single-center-randomize-100583716",false,"NCT06879938","Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize","Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomized Study","Caress","Inclusion Criteria:\n\n* Informed consent signature\n* Willingness to undergo treatment and follow-up evaluations according to the schedule outlined in the protocol\n* Age \\> 18 years\n\nCohort 1:\n\n* Diagnosis of non-metastatic breast cancer (M0\u002FMx according to TNM system) who have undergone surgical and\u002For chemotherapy and\u002For immunotherapy and\u002For radiotherapy and\u002For endocrine treatment.\n* Postmenopausal women (FSH \\> 30 UIIU\u002FL, E2 \\\u003C 20 pg\u002Fml), either naturally or surgically induced, or iatrogenic post-chemotherapy with absent menstrual cycle for at least 6 months; or premenopausal women on treatment with LHRH analog +\u002F- tamoxifen and\u002For aromatase inhibitor for at least 6 months.\n* At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).\n* Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).\n\nCohort 2:\n\n* Postmenopausal women (FSH \\> 30 UI\u002FL, E2 \\\u003C 20 pg\u002Fml), with absent menstrual cycle for at least 6 months, or women who have undergone bilateral adnexectomy at least 6 months ago.\n* At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).\n* Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).\n\nExclusion Criteria:\n\n* Other current therapy aimed at resolving symptoms associated with vulvo-vaginal atrophy, with the exception of the use of lubricants if sexual activity is present;\n* HRT in progress or discontinued for less than 6 months;\n* Ongoing vulvo-vaginal and urinary infections;\n* Bleeding of ndd;\n* Pathological pap-test within the previous 12 months.","FEMALE","18 Years",{"count":65,"type":66},80,"ESTIMATED","INTERVENTIONAL",[69],"NA","The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation Device - VNOD) in improving symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. The primary objective is to assess vaginal dryness improvement one month after treatment, comparing two groups: an experimental group receiving VNOD therapy with hyaluronic acid and a control group using a hyaluronic acid-based gel (Hydeal-D®). Secondary endpoints include the evaluation of additional vaginal symptoms (pain, irritation, itching, sexual health, quality of life) up to six months post-treatment. The study will enroll 80 women (40 with a history of breast cancer and 40 without). Statistical analysis will use chi-square tests and logistic regression to compare symptom severity reduction between the two groups. With a duration of 18 months, the study aims to provide an innovative, non-hormonal treatment option to improve the quality of life for postmenopausal women, particularly those with a history of breast cancer",[72],"Genitourinary Syndrome of Menopause","2025-03-11",{"date":75,"type":76},"2025-03-17","ACTUAL",{"date":78,"type":76},"2023-10-16",{"date":80,"type":66},"2025-12",{"name":5,"class":6},1]