A Randomized, Placebo-controlled, Double-blind, Parallel-group, Dose Response Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function in Men With Hypogonadotropic Hypogonadism
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.
• 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.