[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636918":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":20,"overallStatus":81,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Copenhagen University Hospital at Herlev","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Leflutrozole","EXPERIMENTAL","once-weekly oral Leflutrozole capsule 0.3 mg",[13],"Drug: Leflutrozole, Dose 2",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Leflutrozole, Dose 2","Leflutrozole capsule 0.3 mg once weekly administered orally",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Martin Blomberg Jensen, D.M.Sc.","Herlev Hospital","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Mads Joon Jorsal, MD","CONTACT","+45 38686364","mads.joon.jorsal@regionh.dk",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Emil Brink Wriedt, MD","emil.brink.wriedt@regionh.dk",[36],{"facility":37,"status":20,"city":38,"state":20,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev., Herlev,","Herlev","2100","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],12.43998,55.72366,{"lat":46,"lon":45},[49],{"name":28,"role":29,"phone":50,"phoneExt":20,"email":31},"+45 38 68 63 64",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Martin Blomberg Jensen","Head of Research Department Endocrinology",[56],{"name":57,"class":58},"ReproNovo SA","INDUSTRY","100636918","phase-1-a-novel-aromatase-inhibitor-leflutrozole-for-treatment-of-non-obstructive-azoospermia-100636918",false,"NCT07571928","A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia","The NOVA-NOA Trial A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia A Prospective Interventional Study","NOVA-NOA","Inclusion Criteria:\n\n* Signed informed consent by participant\n* Signed informed consent by participant's partner (must just be obtained before the par-ticipant starts treatment at Visit 1), if applicable, regarding blood samples, data collec-tion about fertility treatment as well as pregnancy and pregnancy outcome\n* 18-55 years\n* Azoospermia verified by at least 2 semen samples, average semen volume \\>= 1,0 ml with no identifiable sign of obstruction (samples taken at Visit -1 and at Visit 0 prior to confirmation of eligibility and dosing).\n* Serum AMH or Inhibin B level above the lower limit of quantification (LLOQ) at screening or within 6 months prior to screening\n* Testosterone \\\u003C 15 nmol\u002FL at screening or within 6 months prior to screening\n* Serum estradiol above the lower limit of normal range (48 pmol\u002FL) at screening or within 6 months prior to screening\n\nExclusion Criteria:\n\n* Klinefelter or other major genetic conditions including large deletions on sex chromosomes\n* Average testis size \\> 20 mL unless obstruction has been excluded\n* TESE procedure \\\u003C ½ year ago\n* LH concentration \\> 15 IU\u002FL at screening\n* Current abuse of steroids\n* BMI \\> 45 kg\u002Fm2\n* Severe chronic diseases requiring daily medication\n* Prior thromboembolic event within the last 24 months\n* Cardiovascular event within the last 6 months judged as significant by the investigator\n* Osteoporosis requiring medical treatment\n* Use of any prescription or non-prescription medication (apart from routine vitamins, occasional use of paracetamol, acetylsalicylic acid, or ibuprofen) which could interfere with pharmacokinetic or pharmacodynamic results, as judged by the investigator, such as:\n\n  * Herbal products and non-routine vitamins\n  * Insulin\n  * Medication such as systemic corticosteroids, tricyclic antidepressants, and atypical antipsychotics\n* Surgery scheduled for the trial duration period, except for minor, non-gastrointestinal surgical procedures at the discretion of the investigator\n* Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial\n* Serum prostate specific antigen (PSA) \\> 3 ng\u002FmL at screening or within 6 months prior to screening\n* Hematocrit \\>50% at screening or within 6 months prior to screening\n* Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the trial, as judged by the investigator","MALE","18 Years","55 Years",{"count":71,"type":72},15,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE1","PHASE2","This clinical interventional study aims to assess whether treatment with with leflutrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian hormone (AMH) or Inhibin B as a positive predictive biomarker.",[79,80],"Infertility Due to Azoospermia","Infertility, Male","NOT_YET_RECRUITING","2026-04-30",{"date":84,"type":85},"2026-05-06","ACTUAL",{"date":87,"type":72},"2026-05-01",{"date":89,"type":72},"2027-08-31",{"name":53,"class":6},1]