[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100199032":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":23,"locations":30,"responsibleParty":43,"collaborators":23,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":23,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":23,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":73,"whyStopped":23,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Janssen-Cilag, S.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gynoclin V","EXPERIMENTAL","One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.",[13],"Drug: Gynoclin V",{"label":15,"type":10,"description":16,"interventionNames":17},"Vagitrol V","One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram\u002Fmilliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.",[18],"Drug: Vagitrol V",[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9],null,{"type":21,"name":15,"description":16,"armGroupLabels":25,"otherNames":23},[15],[27],{"name":28,"affiliation":5,"role":29},"Janssen-Cilag S.A. Clinical Trial","STUDY_DIRECTOR",[31,36],{"facility":23,"status":23,"city":32,"state":33,"zip":23,"country":34,"countryCode":35,"cosmosGeoPoint":23,"geoPoint":23,"contacts":23},"DF","Mexico City","Mexico","MX",{"facility":23,"status":23,"city":33,"state":23,"zip":23,"country":34,"countryCode":35,"cosmosGeoPoint":37,"geoPoint":42,"contacts":23},{"type":38,"coordinates":39},"Point",[40,41],-99.12766,19.42847,{"lat":41,"lon":40},{"type":44,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100199032","phase-3-a-study-to-compare-efficacy-and-safety-of-an-ovule-containing-terconazole-clindamycin-and-fluocinolone-versus-an-ovule-containing-metronidazole-nystatin-and-fluocinolone-in-the-treatment-of-secondary-vulvar-or-vaginal-symptoms-of-infectious-vaginitis-and-infectious-vaginosis-100199032",true,"NCT01867164","A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar\u002F or Vaginal Symptoms of Infectious Vaginitis\u002F and Infectious Vaginosis","A Prospective, Open-Label, Comparative, Parallel Double-Arm, Multicentric Clinical Study to Evaluate the Efficacy of an Ovule With Triple Active Agents (Terconazole, Clindamycin, Fluocinolone) Administered Once Per Day for Three Days Versus an Ovule With Triple Active Agents (Metronidazole, Nystatin, Fluocinolone) Administered Once Per Day for Ten Days to Treat Secondary Vulvar\u002FVaginal Symptoms of Vaginitis\u002FInfectious Vaginosis (Bacterial and\u002For Mycotic and\u002For Parasitic)","Inclusion Criteria:\n\n* Participants presenting clinical symptoms compatible with vaginitis\u002Fbacterial vaginosis, with any of the following symptoms being the reason for the consultation: pruritus (itchiness), vulvar burning, as well as presenting leukorrhea (a clear or white discharge from the vagina, consisting mainly of mucus) as an accompanying symptom\n* Participant who agrees to return at the 7th and 13th day after starting the treatment\n* Participant who agrees to abstain from sexual relations for the 13 days of the study\n* Participant who have signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Participant with a known allergy to vaginal treatments\n* Participants who have received treatment for the current condition in the 10 days before the date of inclusion, or is currently receiving antibiotics (drug used to stop or slow down the growth of germs), antifungals, anti-parasitics or systemic steroids\n* Participant with suspected pregnancy or currently breastfeeding\n* Participant who has received unknown drugs or experimental drugs within the 3 months before inclusion\n* Participant known to be a carrier of a severe (very serious, life threatening) disease that alters the metabolism or excretion of the drugs used (liver or kidney disease)",false,"FEMALE","18 Years","75 Years",{"count":57,"type":58},160,"ACTUAL","INTERVENTIONAL",[61],"PHASE3","The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli).",[64,65],"Vaginitis","Infectious Vaginosis",[64,67,68,69,70,71,72],"Infectious vaginosis","Terconazole","Clindamycin","Fluocinolone","Metronidazole","Nystatin","COMPLETED","2013-11-01",{"date":76,"type":77},"2013-12-24","ESTIMATED",{"date":79,"type":23},"2007-12",{"date":81,"type":58},"2008-12",{"name":5,"class":6},2]