LEFLUTROZOLE for Non-obstructive azoospermia | Male infertility

Inclusion criteria

• {"criterion_text":"- Signed informed consent by participant\n- Signed informed consent by participant’s partner (must just be obtained before the participant starts treatment at Visit 1), if applicable, regarding blood samples, data col-lection 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 < 15 nmol/L at screening or within 6 months prior to screening\n- Serum estradiol above the lower limit of normal range (48 pmol/L) at screening or within 6 months prior to screening"}

Exclusion criteria

• {"criterion_text":"- Klinefelter or other major genetic conditions including large deletions on sex chromo-somes\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: o Herbal products and non-routine vitamins o Insulin o 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/mL 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\n- Average testis size > 20 mL unless obstruction has been excluded\n- TESE procedure < ½ year ago\n- LH concentration > 15 IU/L at screening\n- Current abuse of steroids\n- BMI > 45 kg/m2\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"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is proportion of patients with spermatozoa in the ejaculate at Week 12-20.","definition_or_measurement_approach":"Assessed as the proportion of participants with presence of spermatozoa in the ejaculate measured at Week 12-20."}

Secondary endpoints

• {"endpoint_text":"- Changes in serum reproductive hormones (FSH, LH, Testosterone, Estradiol, Inhibin B, AMH, SHBG)","definition_or_measurement_approach":"Measured changes in listed serum reproductive hormones."}
• {"endpoint_text":"- Changes in the concentration of RANKL, OPG, AMH, and Inhibin B in seminal fluid","definition_or_measurement_approach":"Measured changes in concentrations of listed markers in seminal fluid."}
• {"endpoint_text":"- Change in serum Inhibin B/FSH ratio, Testosterone/LH ratio, Testosterone/Estradiol and AMH/Testosterone ratio","definition_or_measurement_approach":"Calculated changes in specified serum hormone ratios."}
• {"endpoint_text":"- Changes in BMI","definition_or_measurement_approach":"Change in body mass index."}
• {"endpoint_text":"- Changes in HbA1c, fasting- glucose, c-peptide, insulin and HOMA-IR","definition_or_measurement_approach":"Measured changes in listed glycaemic and insulin-resistance biomarkers."}
• {"endpoint_text":"- Changes in lipids (total cholesterol, LDL, HDL and triglycerides)","definition_or_measurement_approach":"Measured changes in listed lipid parameters."}
• {"endpoint_text":"- Changes in hematocrit","definition_or_measurement_approach":"Measured change in hematocrit."}
• {"endpoint_text":"- Change in circulating markers of bone resorption and formation (PINP and CTX)","definition_or_measurement_approach":"Measured changes in circulating PINP and CTX."}
• {"endpoint_text":"- Change in mineral homeostasis in spot urine (albumin, calcium, magnesium, iron, ferritin, phosphate, zinc, bicarbonate, citrate)","definition_or_measurement_approach":"Measured changes in listed urinary minerals and markers from spot urine samples."}
• {"endpoint_text":"- Change in mineral homeostasis in serum (albumin, calcium, phosphate, magnesium, iron, ferritin, transferrin, hepcidin, zinc)","definition_or_measurement_approach":"Measured changes in listed serum minerals and related markers."}
• {"endpoint_text":"- Change in mineral homeostasis in seminal fluid (albumin, calcium, phosphate, magne-sium, iron, ferritin, zinc)","definition_or_measurement_approach":"Measured changes in listed seminal fluid minerals and markers."}
• {"endpoint_text":"- Changes in calciotropic hormones (PTH, Klotho and FGF23)","definition_or_measurement_approach":"Measured changes in listed calciotropic hormones."}
• {"endpoint_text":"- Changes in serum vitamin D metabolites (cholecalciferol, 25OHD, 24,25OHD, 1,25OH2D3 and cholecalciferol/25OHD ratio, 25OHD/24,25OHD ratio)","definition_or_measurement_approach":"Measured changes in listed serum vitamin D metabolites and ratios."}
• {"endpoint_text":"- Changes in androstenedione, cortisone and DHEAS","definition_or_measurement_approach":"Measured changes in listed steroid hormones."}
• {"endpoint_text":"- Plasma and semen concentrations of leflutrozole in the participant and plasma concentrations of leflutrozole in the female partner","definition_or_measurement_approach":"Measured leflutrozole concentrations in plasma and semen of participants and plasma of female partners."}
• {"endpoint_text":"- Change in sperm count, concentration, motility, and morphology when possible.","definition_or_measurement_approach":"Measured changes in sperm count, concentration, motility, and morphology where assessment is possible."}

Denmark

Earliest CTIS Part Ii Submission Date

19-02-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

47

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Herlev Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Health care"}