[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660331":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":11,"studyPopulation":11,"armGroups":50,"interventions":72,"overallOfficials":94,"centralContacts":99,"locations":109,"responsibleParty":206,"collaborators":11,"id":209,"slug":210,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":11,"eligibilityCriteria":215,"healthyVolunteers":211,"sex":216,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":11,"studyType":222,"phases":223,"briefSummary":225,"conditions":226,"keywords":11,"overallStatus":228,"whyStopped":11,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":11},[9,13,15,17,21,23,25,27,29,31],{"measure":10,"description":11,"timeFrame":12},"Incidence of TEAEs.",null,"From Day 1 to Day 93 (EOS visit)",{"measure":14,"description":11,"timeFrame":12},"Incidence of SAEs",{"measure":16,"description":11,"timeFrame":12},"Clinically significant changes in Safety Laboratory Parameters as per protocol",{"measure":18,"description":19,"timeFrame":20},"Assess Lactobacillus crispatus dominance in vaginal microbiota","Proportion of participants with Lactobacillus crispatus dominance, defined as \\>50% relative abundance based on metagenomic sequencing of vaginal microbiota samples.","3 weeks after product use cessation",{"measure":22,"description":11,"timeFrame":12},"Clinically significant changes in Physical examinations",{"measure":24,"description":11,"timeFrame":12},"Self-Reported Symptoms- abnormal vaginal odor",{"measure":26,"description":11,"timeFrame":12},"Self-Reported Symptoms- pain, tenderness",{"measure":28,"description":11,"timeFrame":12},"Self-Reported Symptoms- dyspareunia",{"measure":30,"description":11,"timeFrame":12},"Self-Reported Symptoms- dysmenorrhea\u002Fcramping with menses",{"measure":32,"description":11,"timeFrame":12},"Self-Reported Symptoms- vaginal vulvar itching",[34,37],{"measure":35,"description":36,"timeFrame":20},"Recurrence of bacterial vaginosis (BV)","Proportion of participants with recurrent bacterial vaginosis, defined as Nugent score ≥7.",{"measure":38,"description":19,"timeFrame":39},"Lactobacillus crispatus dominance in the vaginal microbiota","8 weeks and 12 weeks after product use cessation",{"allocation":41,"interventionModel":42,"interventionModelDescription":11,"primaryPurpose":43,"observationalModel":11,"timePerspective":11,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":47},"DOUBLE","double blinding for Arms 1-4 while Arm 5 will remain unblinded",[48,49],"PARTICIPANT","INVESTIGATOR",[51,56,60,64,68],{"label":52,"type":53,"description":11,"interventionNames":54},"Arm 1","EXPERIMENTAL",[55],"Drug: metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo",{"label":57,"type":53,"description":11,"interventionNames":58},"Arm 2",[59],"Drug: metronidazole (MTZ)+ LCFA-01 + LC103 placebo",{"label":61,"type":53,"description":11,"interventionNames":62},"Arm 3",[63],"Drug: metronidazole (MTZ)+ LC103 + LCFA-01 placebo",{"label":65,"type":53,"description":11,"interventionNames":66},"Arm 4",[67],"Drug: metronidazole (MTZ)+ LC103+ LCFA-01",{"label":69,"type":53,"description":11,"interventionNames":70},"Arm 5",[71],"Drug: LCFA-01 + LC103",[73,78,82,86,90],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":11},"DRUG","metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo","Route of Administration:\n\nMTZ- Oral LCFA-01 placebo- Vaginal LC103 placebo- Vaginal",[52],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":11},"metronidazole (MTZ)+ LCFA-01 + LC103 placebo","Route of Administration:\n\nMTZ- Oral LCFA-01- Vaginal LC103 placebo- Vaginal",[57],{"type":74,"name":83,"description":84,"armGroupLabels":85,"otherNames":11},"metronidazole (MTZ)+ LC103 + LCFA-01 placebo","Route of Administration:\n\nMTZ- Oral LCFA-01 placebo- Vaginal LC103- Vaginal",[61],{"type":74,"name":87,"description":88,"armGroupLabels":89,"otherNames":11},"metronidazole (MTZ)+ LC103+ LCFA-01","Route of Administration:\n\nMTZ- Oral LCFA-01- Vaginal LC103- Vaginal",[65],{"type":74,"name":91,"description":92,"armGroupLabels":93,"otherNames":11},"LCFA-01 + LC103","Route of Administration:\n\nLCFA-01- Vaginal LC103- Vaginal",[69],[95],{"name":96,"affiliation":97,"role":98},"Christopher Moller, Dr.","University of the Sunshine Coast Clinical Trials Maroochydore, QLD","PRINCIPAL_INVESTIGATOR",[100,105],{"name":101,"role":102,"phone":103,"phoneExt":11,"email":104},"Douglas Kwon, Dr.","CONTACT","+1 (857) 268-7160","dkwon@mgh.harvard.edu",{"name":106,"role":102,"phone":107,"phoneExt":11,"email":108},"Dr. Caroline Mitchell, MD, PHD","+16177242182","caroline.mitchell@mgh.harvard.edu",[110,129,145,157,173,191],{"facility":111,"status":11,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"Emeritus Research Sydney","Sydney","New South Wales","2019","Australia","AU",{"type":118,"coordinates":119},"Point",[120,121],151.20732,-33.86785,{"lat":121,"lon":120},[124,128],{"name":125,"role":102,"phone":126,"phoneExt":11,"email":127},"Danielle Corish, Dr","02 8964 8186","daniellecorish@emeritusresearch.com",{"name":125,"role":98,"phone":11,"phoneExt":11,"email":11},{"facility":130,"status":11,"city":131,"state":132,"zip":133,"country":115,"countryCode":116,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"University of the Sunshine Coast Clinical Trials Maroochydore","Maroochydore","Queensland","4558",{"type":118,"coordinates":135},[136,137],153.09953,-26.66008,{"lat":137,"lon":136},[140,144],{"name":141,"role":102,"phone":142,"phoneExt":11,"email":143},"Christopher Moller, Dr","+61 5456 5265","cmoller@usc.edu.au",{"name":141,"role":98,"phone":11,"phoneExt":11,"email":11},{"facility":146,"status":11,"city":147,"state":132,"zip":148,"country":115,"countryCode":116,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"University of the Sunshine Coast Clinical Trials Morayfield","Morayfield","4506",{"type":118,"coordinates":150},[151,152],152.94907,-27.10876,{"lat":152,"lon":151},[155,156],{"name":141,"role":102,"phone":142,"phoneExt":11,"email":143},{"name":141,"role":98,"phone":11,"phoneExt":11,"email":11},{"facility":158,"status":11,"city":159,"state":160,"zip":161,"country":115,"countryCode":116,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Emeritus Research Camberwell","Camberwell","Victoria","3124",{"type":118,"coordinates":163},[164,165],145.0694,-37.84205,{"lat":165,"lon":164},[168,172],{"name":169,"role":102,"phone":170,"phoneExt":11,"email":171},"Sewa Rijal, Dr","03 9509 6166","sewarijal@emeritusresearch.com",{"name":169,"role":98,"phone":11,"phoneExt":11,"email":11},{"facility":174,"status":11,"city":175,"state":176,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"CAPRISA Centre for the AIDS Programme of Research","Durban","KwaZulu-Natal","4001","South Africa","ZA",{"type":118,"coordinates":181},[182,183],31.0292,-29.8579,{"lat":183,"lon":182},[186,190],{"name":187,"role":102,"phone":188,"phoneExt":11,"email":189},"Disebo Potloane, Dr.","+27 (0)31 655 0687","disebo.makhaza@caprisa.org",{"name":187,"role":98,"phone":11,"phoneExt":11,"email":11},{"facility":192,"status":11,"city":193,"state":176,"zip":194,"country":178,"countryCode":179,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"FRESH (Females Rising through Education, Support and Health)","Umlazi","4066",{"type":118,"coordinates":196},[197,198],30.88333,-29.96667,{"lat":198,"lon":197},[201,205],{"name":202,"role":102,"phone":203,"phoneExt":11,"email":204},"Rosie Mgqibisa, Dr","+2782 726 4430","mngqibisa@ecarefoundation.com",{"name":202,"role":98,"phone":11,"phoneExt":11,"email":11},{"type":98,"investigatorFullName":207,"investigatorTitle":208,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Douglas Kwon","Principle Investigator","100660331","phase-1-a-study-to-test-new-investigational-drugs-lcfa-01and-lc103-for-bacterial-vaginosis-bv-treatment-100660331",false,"NCT07875673","A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment","A Phase 1b Study of Intravaginal Products, LCFA-01 and LC103, for Bacterial Vaginosis Treatment","Inclusion Criteria:\n\n* Diagnosed with bacterial vaginosis, defined by Nugent score ≥ 7, at Screening.\n* Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the site PI or designee.\n* Negative testing for sexually transmitted infections (STIs) that would require antibiotic treatment (STIs: syphilis, trichomonas, gonorrhea, chlamydia) at Screening.\n* Not pregnant at Screening and Enrollment.\n* Regular menstrual cycles or on stable hormonal contraception.\n\nExclusion Criteria:\n\n* Positive for Candida spp. by microscopy, culture, or nucleic acid-based testing at screening and not willing to receive concurrent oral antifungal treatment.\n* Participants who have undergone hysterectomy (total or supracervical) or trachelectomy.\n* History of\n\n  1. Cancer of the female reproductive tract\n  2. Uncontrolled recurrent genital herpes simplex infection, defined by at least 1 active episode in the past 6 months.\n  3. Significant coronary artery disease, myocardial infarction, chronic obstructive pulmonary disease, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the site PI or designee will compromise ability to participate in the study.\n  4. Any disease that may require genital corticosteroid administration during the study period. Inhaled, intranasal, and topical corticosteroids for other parts of the body are allowed.\n  5. Regular heavy menstrual bleeding to an extent that may interfere with study product use or protocol specified assessments, in the judgement of the investigator\n* History of autoimmune disease including, but not limited to, Hashimoto's thyroiditis, pernicious anemia, Addison's disease, rheumatoid arthritis, lupus, multiple sclerosis, myasthenia gravis, Grave's disease, celiac disease, sprue, psoriasis, sarcoidosis, scleroderma, diabetes mellitus, etc. Evidence of autoimmune disease or receiving immunosuppressive therapy at the discretion of site PI or designee.\n* Vaginal cleansing practices within 7 days prior to dosing.\n* Patients with human immunodeficiency virus (HIV) infection, regardless of treatment status.\n* History of severe allergic or anaphylactic reactions, or sensitivity to the IP, its constituents, or metronidazole.\n* Use of a hormonal vaginal ring device.\n* Vital signs with systolic blood pressure \\> 180 mm\u002FHg or diastolic blood pressure \\> 110 mm\u002FHg at Screening.","FEMALE","18 Years","40 Years",{"count":220,"type":221},280,"ESTIMATED","INTERVENTIONAL",[224],"PHASE1","This Phase 1b study will evaluate different combinations of LCFA-01, LC103, and the antibiotic metronidazole in women with bacterial vaginosis (BV). Participants will be randomly assigned to one of five treatment groups and followed for approximately 13 weeks to assess the safety of the treatments, how well they work to treat BV, and their effects on the vaginal microbiome.\n\nUp to 280 participants will be enrolled in this study",[227],"Bacterial Vaginosis","NOT_YET_RECRUITING","2026-10-09",{"date":231,"type":232},"2026-10-15","ACTUAL",{"date":234,"type":221},"2027-02-03",{"date":236,"type":221},"2028-05-20",{"name":5,"class":6},6]