[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497174":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":36,"responsibleParty":56,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":20,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":20,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Queen's Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","EXPERIMENTAL","This is a single-arm study. all participants are assigned to this arm. all study participants will receive Phexxi, the study drug. 8 pre-filled vaginal inserters with vaginal gel, Phexxi, will be provided to each of the participants with verbal and written instructions for application. Patients will be instructed to use Phexxi twice per week, on the same days every week.",[13],"Drug: Phexxi",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Phexxi","intravaginal gel twice weekly for 4 weeks.",[9],null,[22,26,28],{"name":23,"affiliation":24,"role":25},"Olivia Manayan, MD, MPH","University of Hawaii","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":25},"Bliss Kaneshiro, MD, MPH",{"name":29,"affiliation":24,"role":25},"Corrie Miller, DO",[31],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Olivia H Manayan, MD, MPH","CONTACT","808-348-7859","omanayan@hawaii.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Queens Medical Center, 1004 Clinic POB1","RECRUITING","Honolulu","Hawaii","96813","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-157.85833,21.30694,{"lat":49,"lon":48},[52,54],{"name":32,"role":33,"phone":53,"phoneExt":20,"email":20},"8083487859",{"name":55,"role":25,"phone":20,"phoneExt":20,"email":20},"Olivia H Manayan, MD MPH",{"type":25,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Olivia Manayan, MD MPH","PGY-2, University of Hawaii Ob\u002FGyn Residency",[60],{"name":61,"class":62},"University of Hawaii Foundation","UNKNOWN","100497174","early-phase-1-exploring-the-effects-of-an-intravaginal-lactic-acid-gel-on-the-vaginal-microbiome-100497174",false,"NCT05753813","Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome","Inclusion Criteria:\n\n* Age 18-54\n* Female\n* Pre-menopausal\n* Can speak and read in English\n* Displays capacity for informed consent\n* Has had 2 or more documented and\u002For self-reported episodes of symptomatic BV or candida infection in the last year, requiring, over-the-counter or prescription treatment\n\nExclusion Criteria:\n\n* Pregnant or trying to become pregnant\n* Post-menopausal\n* Using NuvaRing device\n* A past medical history of kidney disease, recurrent UTI, and\u002For urinary tract abnormalities\n* Current UTI\n* Using Phexxi as a contraceptive during the collection period of the study",true,"FEMALE","18 Years","54 Years",{"count":74,"type":75},22,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.",[81,82],"Bacterial Vaginosis","Vulvovaginal Candidiasis","2026-02-18",{"date":85,"type":86},"2026-02-20","ACTUAL",{"date":88,"type":86},"2023-12-15",{"date":90,"type":75},"2026-12-30",{"name":5,"class":6},1]