A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function in Men With Hypogonadotropic Hypogonadism

Eligibility 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.
• * 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.