[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kevin Hellman\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"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":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Dysmenorrhea","Menstrual Pain",[31,32,33,34,35,36],"sildenafil","vaginal sildenafil","uterine contractility","cine MRI","dysmenorrhea","pelvic pain","NOT_YET_RECRUITING","2026-03-31",{"date":40,"type":41},"2026-04-02","ACTUAL",{"date":43,"type":22},"2026-05",{"date":45,"type":22},"2027-10",{"name":47,"class":48},"Kevin Hellman","OTHER",""]