[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556828":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":37,"overallOfficials":18,"centralContacts":18,"locations":45,"responsibleParty":68,"collaborators":18,"id":71,"slug":18,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":18,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":18,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":96,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Atlantic Health System","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"User Experience Questionnaire","Validation of User Needs Requirements as well as patient experience","24 hours",[14],{"measure":15,"description":16,"timeFrame":17},"change in vaginal pH","change in vaginal pH before and after using Livi, and before and after NOT using Livi","2-6 hours, and 10-14 hours after use",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NON_RANDOMIZED","SINGLE_GROUP","PREVENTION",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","LiviWell's consumer hygiene device is a post-coital vaginal insert called \"Livi\". Livi is comprised of an applicator, with a medical-grade polyurethane foam and retrieval string. It is designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal. The result is a decrease in discharge\u002Fdripping and vaginal odor. The investigators also believe the device will lower vaginal pH, as the typical premenopausal vaginal pH is acidic (pH \\~4), and semen has an alkaline pH (\\~8). The resulting pH imbalance in sexually-active women not using male condoms had been shown to lead to vaginal odor, dripping, discomfort. Furthermore, the risk of bacterial vaginosis (BV) is higher in women who are sexually active and not using male condoms. The investigators have additional studies planned to evaluate if the product lowers the risk of BV.\n\nThe current study will be used to validate user needs requirements for the study device, understand pH changes after insertion, and evaluate change in symptoms of vaginal odor, discharge\u002Fdripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"pH subset","EXPERIMENTAL","This subset of patients (n=100) will be checking their vaginal pH at various time intervals (before, 2-6 hours after, and 10-14 hours after sex).",[32],"Device: LiviWell Postcoital Vaginal Insert",{"label":34,"type":29,"description":35,"interventionNames":36},"Main Cohort","This subset of patients (n=900) will be providing user feedback on the study device, and will not be checking their vaginal pH",[32],[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DEVICE","LiviWell Postcoital Vaginal Insert","subjects will use Livi within minutes of completion of sex, and will remove study device in under an hour.",[34,28],[44],"Livi",[46],{"facility":47,"status":18,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Garden State Urology","Mountain Lakes","New Jersey","07046","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-74.43293,40.89482,{"lat":57,"lon":56},[60,65],{"name":61,"role":62,"phone":63,"phoneExt":18,"email":64},"Cathy Smith, MA","CONTACT","973-537-5557","csmith@gsunj.com",{"name":66,"role":67,"phone":18,"phoneExt":18,"email":18},"Michael Ingber, MD","PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Michael Ingber","Attending Physician","100556828",false,"NCT06530186","Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters","Inclusion Criteria:\n\n* Over 18 (for pH subset, 18-45)\n* Sexually-active with biological men\n* Willing and able to use product\n* Resides in continental USA\n* Understands, reads, writes, and speaks English\n\nExclusion Criteria:\n\n* Currently Pregnant or are trying to conceive\n* Unable to use device due to poor motor function\n* Unable to sign informed consent",true,"FEMALE","18 Years",{"count":80,"type":81},1000,"ESTIMATED","INTERVENTIONAL",[84],"NA","LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.",[87,88,89,90],"Vaginal Infection","Vaginal Discharge","Vaginosis","Sexual Dysfunction",[92,93,94,95],"vaginal odor","vaginal discharge","postcoital dripping","vaginal microbiome","NOT_YET_RECRUITING","2024-07-27",{"date":99,"type":100},"2024-07-31","ACTUAL",{"date":102,"type":81},"2024-08-01",{"date":104,"type":81},"2025-01-31",{"name":5,"class":6},1]