[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"candidal-vaginitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:candidal-vaginitis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100645748","efficacy-and-safety-of-a-vaginal-ovule-medical-device-for-bacterial-vaginosis-and-candidal-vaginitis-rovul25-100645748",false,"NCT07703241","Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).","Evaluation of the Efficacy and Safety of a Vaginal Ovule Medical Device in the Treatment of Bacterial Vaginosis and Candidal Vaginitis: A Randomized, Placebo-Controlled, Two-Arm Parallel-Group Study.","ROVUL-25","Inclusion Criteria:\n\n* Female sex\n* Age 18 to 60 years\n* Able to understand and sign informed consent\n* Able to understand and comply with protocol requirements\n* Negative pregnancy test\n* Negative HIV test\n* Not taking, and agreeing not to take, any other medication or medical device for the duration of the study, except the elective antibacterial or antifungal treatment for BV or VVC\n* Presenting symptoms suggestive of BV or VVC at screening (leukorrhea, itching, burning)\n* Confirmed clinical diagnosis of bacterial vaginosis (yellow-green or gray vaginal discharge; vaginal pH \\> 4.5; positive whiff test\u002Ffishy odor with potassium hydroxide), OR\n* Confirmed clinical diagnosis of vulvovaginal candidiasis (gynecological examination with itching, burning, thick white discharge; vaginal pH typically \\\u003C 4.5; vaginal swab confirmation of \\*Candida\\* spp.)\n\nExclusion Criteria:\n\n* Male sex\n* Age \\\u003C 18 or \\> 60 years\n* Pregnant, suspected pregnant, or planning pregnancy during the study period\n* Breastfeeding\n* Not self-sufficient\n* Unwilling\u002Funable to cooperate with study procedures\n* Unable to attend the study site within the required timeframe\n* Judged unsuitable by the investigator due to other conditions incompatible with enrollment requiring pharmacological treatment\n* HIV-positive \u002F acquired immunodeficiency\n* Known allergy to components of the investigational products (active or placebo)\n* Presence of vaginal infections other than BV or VVC\n* Alcohol, drug, nicotine, or excessive caffeine\u002Ftheine abuse\n* Use of vaginal or systemic antifungal\u002Fantibiotic treatment within the 7 days prior to enrollment\n* Taking any other medication or medical device during the study period, except the elective treatment for BV\u002FVVC\\*\n* Systemic or immunosuppressive conditions interfering with symptom interpretation\n* Participation in another clinical study within the previous 30 days\n\n  * If pharmacological treatment becomes necessary, this must be reported to the Principal Investigator, who will assess on a case-by-case basis whether the subject should be excluded.","FEMALE","18 Years","60 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a randomized, double-blind, placebo-controlled, two-arm parallel-group clinical study evaluating the efficacy and safety of INTIMIQUE OVULI, a Class IIa vaginal medical device, in adult women (18-60 years) diagnosed with bacterial vaginosis (BV) or vulvovaginal candidiasis (VVC). Participants are randomized 1:1 to receive the active device or a placebo ovule, in addition to standard-of-care antibacterial or antifungal pharmacological treatment, depending on diagnosis. Treatment is administered in three cycles (7 consecutive days, then 4 consecutive days, then 3 consecutive days, each separated by washout periods), followed by a 2-month follow-up. The study is a post-market clinical investigation conducted as part of the device's transition from MDD to MDR.",[28,29],"Bacterial Vaginosis","Candidal Vaginitis","NOT_YET_RECRUITING","2026-07-08",{"date":33,"type":34},"2026-07-14","ACTUAL",{"date":36,"type":22},"2026-07-09",{"date":38,"type":22},"2026-11-30",{"name":40,"class":41},"ROELMI HPC","INDUSTRY"]