[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100252916":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":36,"collaborators":34,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":34,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":34,"enrollmentInfo":47,"targetDuration":34,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":34,"overallStatus":56,"whyStopped":34,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":34},{"fullName":5,"class":6},"Farmoquimica S.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Only treatment","EXPERIMENTAL","two weekly applications (monday and thursday or tuesday and friday) for 12 weeks",[13],"Drug: Hidra1",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Hidra1","Parameters: Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none \u002F inflamed area ; 2 = no \u002F NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal.\n\nWill be described through the Media and Standard Deviation or median and interquartile rank , as Minimum and Maximum.\n\nScala: pH tape: It will be measured by its own value. Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.",[9],[21,22,23],"Parameters: Vaginal health index (VHI)","Scala: pH tape","Questionnaire: Sexual Function Index female (FSFI)",[25],{"name":26,"affiliation":27,"role":28},"Thales Braga, Analist","Famorquimica SA","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Fabiene Vale, Physician","CONTACT","55 31 91878133",null,"fabienebcv@yahoo.com.br",{"type":37,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100252916","phase-4-evaluate-the-efficacy-safety-and-tolerability-of-a-non-hormonal-intravaginal-gel-in-postmenopausal-women-with-symptoms-of-vaginal-dryness-100252916",false,"NCT02571127","Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.","Ph IV , Longitudinal, Prospective, Open Label, Non-comparative, to Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.","Inclusion Criteria:\n\n* Women over the age of 40 years.\n* in healthy postmenopausal women (not menstruating for more than one year).\n* Women with vaginal dryness (VHI score in item vaginal moisture between 1-3)\n* women with active sex lives of at least one sexual intercourse in the month\n* Women without a history of sensitivity to similar formulations.\n* understanding and signing an informed consent agreement.\n\nExclusion Criteria:\n\n* Women in using other intravaginal gel moisturizer.\n* Women diagnosed with cancer.\n* Women with disease or condition that, in the opinion of the gynecologist, could affect the test results.\n* Women using hormone replacement therapy in the last 3 months.\n* Absence of history or visible evidence of chronic skin disease or regional infections.\n* Women with genital herpes, vaginal infections or urinary tract infection.\n* Pregnant women and nursing mothers.\n* Personal history of allergy and hypersensitivity to any product of feminine hygiene.","FEMALE","40 Years",{"count":48,"type":49},46,"ESTIMATED","INTERVENTIONAL",[52],"PHASE4","Primary: Evaluation of improved vaginal moisture in postmenopausal women.\n\nSecondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of adherence to study treatment by patient diary, assessing the acceptability of the product and subjective assessment of the patient as the itching and stinging \u002F burning, beyond the safety assessment.",[55],"Vaginal Atrophy","UNKNOWN","2015-10-06",{"date":59,"type":49},"2015-10-08",{"date":61,"type":34},"2015-10",{"date":63,"type":49},"2016-03",{"name":5,"class":6}]