a clinical trial evaluating the efficacy and safety of leflutrozole on testicular function in men with hypogonadotropic hypogonadism

Conditions: Hypogonadotropic Hypogonadism

Summary: the goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men with hypogonadotropic hypogonadism, a condition that affects hormone levels and fertility. it will also study the safety of leflutrozole. the main questions it aims to answer are: * does leflutrozole improve semen quality? * what medical problems do participants experience when taking leflutrozole? researchers will compare leflutrozole to a placebo (a look-alike substance that contains no drug). participants will: * take leflutrozole or a placebo orally once a week for 16 weeks. * visit the clinic every 4 weeks for checkups and tests. * provide semen samples to measure changes in semen quality. * have their blood tested to measure hormone levels and ensure safety. * be monitored for any side effects.


Eligibility criteria:
inclusion criteria: * signed informed consent form prior to any-related trial activity. * adult men aged 18-49 years (both inclusive). * low serum total testosterone concentration on two occasions. * serum sex hormone binding globulin within or above normal range at screening. * serum estradiol (e2) level within or above normal range at screening. * serum luteinizing hormone level within or below normal range at screening. * low total motile sperm count in two samples. * semen volume ≥1.0 ml in two samples. * ability to understand and comply with the requirements of the protocol. exclusion criteria: * anatomical abnormalities of the testes or malignant or benign tumors of the testes. * pituitary or hypothalamic disease. * prostate disease. * treatment with one or more of the following prescription drugs or over-the-counter medications or supplements for 6 months prior to the screening visit: 1. compounds with androgenic or estrogenic properties (i.e., agonist or antagonist) or that affect production of sex hormones. 2. 5-α reductase inhibitors, e.g., finasteride and dutasteride. 3. fertility drugs, including clomiphene, fsh, hmg and hcg preparations. 4. growth hormone. 5. opioid-receptor antagonists, e.g., naloxone and long-acting opioids. 6. selective α-adrenergic-receptor antagonists (alpha blockers). 7. topical or systemic testosterone replacement therapy (trt). 8. anabolic steroids. * inability to reliably produce the required semen samples for trial assessments due to significant erectile dysfunction, anorgasmia, or other reasons. * participation in any clinical trial using clinical intervention within 3 months before the screening visit or 5 half-lives of investigational product administration, whichever is shorter. * any clinically significant 12-lead ecg abnormalities at screening. * known history of thromboembolic disease. * grade 3 lower extremity edema. * known cardiovascular disease. * known history of osteoporosis or fragility fractures. * known moderate or severe impairment of renal or hepatic function. * untreated diagnosis of sleep apnea. * history of cancer within the last 5 years. * known alcohol and/or drug abuse within the last 12 months prior to randomization or evidence of such abuse indicated by the laboratory results during the screening assessments. * known chronic opioid use and/or misuse within the last 12 months prior to randomization. * any psychiatric or medical disorder or circumstance, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol. * hypersensitivity to any active ingredients or excipients in the medicinal products used in this trial.