[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632028":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":65,"collaborators":32,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":32,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":97,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Endeavor Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaginal sildenafil","EXPERIMENTAL","Participants receive a single 100 mg vaginal sildenafil citrate suppository during one menstrual treatment visit. In the crossover design, the same participants receive matching placebo during the other menstrual treatment visit.",[13],"Drug: Sildenafil citrate vaginal suppository",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive a single matched placebo vaginal suppository during one menstrual treatment visit. In the crossover design, the same participants receive vaginal sildenafil during the other menstrual treatment visit.",[19],"Drug: Placebo vaginal suppository",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sildenafil citrate vaginal suppository","A single 100 mg vaginal sildenafil citrate suppository compounded in an emulsifying MBK base is administered during one treatment period of the crossover study.",[9],[27],"Vaginal sildenafil 100 mg",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo vaginal suppository","A single matched placebo vaginal suppository without active sildenafil is administered during one treatment period of the crossover study.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Frank Tu, MD, MPH","EndeavorHealth, Department of Obstetrics & Gynecology","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Kevin Hellman, PhD","CONTACT","847-570-2622","kevin.hellman@endeavorhealth.org",[45],{"facility":46,"status":32,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Evanston Hospital","Evanston","Illinois","60201","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-87.69006,42.04114,{"lat":56,"lon":55},[59,62,64],{"name":35,"role":41,"phone":60,"phoneExt":32,"email":61},"847-644-0494","frank.tu@endeavorhealth.org",{"name":63,"role":41,"phone":32,"phoneExt":32,"email":32},"Kevin",{"name":35,"role":37,"phone":32,"phoneExt":32,"email":32},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Kevin Hellman","Senior Research Scientist","100632028","phase-1-vaginal-sildenafil-for-primary-dysmenorrhea-100632028",false,"NCT07508358","Vaginal Sildenafil for Primary Dysmenorrhea","Vaginal Sildenafil for Primary Dysmenorrhea: A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Mechanistic Study","SILDYS","Inclusion Criteria:\n\n* Female sex assigned at birth\n* Age 18 to 35 years\n* History of moderate-to-severe primary dysmenorrhea\n* Regular menstrual cycles of approximately 21 to 35 days\n* Willing and able to complete 2 menstrual treatment visits in separate menstrual cycles\n* Able to provide informed consent\n* Able to comply with study procedures, including MRI procedures and vaginal self-administration of study product\n\nExclusion Criteria:\n\n* Known hypersensitivity to sildenafil or any formulation component\n* Current use of nitrates or nitric oxide donors\n* Current use of potent CYP3A4 inhibitors or potent CYP3A4 inducers\n* Current use of another phosphodiesterase type 5 inhibitor\n* Uncontrolled hypertension, near-hypotension, or other clinically significant hemodynamic instability\n* Clinically significant cardiovascular disease\n* Clinically significant electrocardiographic abnormality, as judged by the investigator\n* Clinically significant laboratory abnormality, as judged by the investigator\n* Severe hepatic impairment or severe renal impairment\n* Active pelvic infection\n* Contraindication to MRI or factors that would impair MRI safety or interpretability, including certain metallic implants, metallic injury, claustrophobia, or intrauterine device-related artifact\n* Pregnant or breastfeeding\n* Any condition that, in the opinion of the investigator, would increase risk or interfere with study participation","FEMALE","18 Years","35 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This phase 1 randomized, double-blind, placebo-controlled, two-period crossover trial will evaluate whether a single 100 mg vaginal sildenafil citrate suppository reduces uterine hypercontractility during menstruation in adults with moderate-to-severe dysmenorrhea. Uterine contractility will be measured using cine magnetic resonance imaging (MRI). Key secondary objectives are to evaluate acute menstrual pain reduction over 4 hours, characterize limited systemic exposure using a single 4-hour plasma sildenafil concentration, and assess short-term safety and tolerability.",[88,89],"Dysmenorrhea","Menstrual Pain",[91,92,93,94,95,96],"sildenafil","vaginal sildenafil","uterine contractility","cine MRI","dysmenorrhea","pelvic pain","NOT_YET_RECRUITING","2026-03-31",{"date":100,"type":101},"2026-04-02","ACTUAL",{"date":103,"type":82},"2026-05",{"date":105,"type":82},"2027-10",{"name":67,"class":6},1]