[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555630":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Oxagon","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MenOxy","ACTIVE_COMPARATOR","The investigational product will contain a Plastic tube containing 36 g of study product (gel) and a Vaginal calibrated plastic applicator for dose (1 ml) administration. The active constituent is oxytocin 600 IU\u002Fml dissolved in a gel based on Hypromellose with a pH of 3.8.",[13],"Drug: Oxytocin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","The placebo gel will match the IP gel (Hypromellose) with a pH of 3.8, without oxytocin.",[19],"Other: Hydroxypropyl methylcellulose",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oxytocin","Oxytocin gel 600 IU . 1mg\u002Fg",[9],null,{"type":28,"name":29,"description":15,"armGroupLabels":30,"otherNames":26},"OTHER","Hydroxypropyl methylcellulose",[15],[32],{"name":33,"affiliation":34,"role":35},"Assem Anwar","Azhar Univeristy","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Ibrahim Gado","CONTACT","00201094742244","ibrahim.gado@oxagon-ab.com",[43],{"facility":5,"status":26,"city":44,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Cairo","Egypt","EG",{"type":48,"coordinates":49},"Point",[50,51],31.24967,30.06263,{"lat":51,"lon":50},[54,55,58],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":56,"role":39,"phone":26,"phoneExt":26,"email":57},"Khaled Prince","khaled.prince@clinmax.net",{"name":59,"role":35,"phone":26,"phoneExt":26,"email":26},"Asem Anwar",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100555630","phase-3-the-efficacy-of-topical-vaginal-oxytocin-gel-in-postmenopausal-women-with-vulvovaginal-atrophy-100555630",false,"NCT06514586","The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy","The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.\n2. Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and\u002For dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.\n\n4\\. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH \\> 5.0 at screening 6. A level of estradiol ≤ 30 pg\u002FmL and a level of Follicle Stimulating Hormone (FSH) \\> 40 milli International Units (mIU)\u002Fml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits\n\nExclusion Criteria:\n\n1. Previous treatment with other local non-hormonal moisturizers\u002Fhormonal products within 1 month or use of lubricants within 1 week prior to inclusion.\n2. Women taking systemic hormone replacement or pills within the last 6 months.\n3. Current or history of endometrial hyperplasia or uterine\u002Fendometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding\n4. Any untreated urogenital infection within 14 days prior to randomization.\n5. Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.\n6. Critically ill patients.\n7. Patients with severe renal impairment (GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2 as measured by the Cockcroft-Gault formula).\n8. Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.\n9. Patients with known or suspected allergy or any contraindications to oxytocin.",true,"FEMALE","47 Years","65 Years",{"count":74,"type":75},244,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.",[81,82,83],"Vaginal Atrophy","Genitourinary Syndrome of Menopause","Vulvar Atrophy",[85,86,87,88],"vulvovaginal atrophy","postmenopause","vulvovaginal","atrophy","NOT_YET_RECRUITING","2024-07-17",{"date":92,"type":93},"2024-07-23","ACTUAL",{"date":95,"type":75},"2024-09",{"date":97,"type":75},"2025-08",{"name":5,"class":6},1]