A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function

Conditions

• Semen Quality

Eligibility Criteria

Sex

MALE

Age

18 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Leflutrozole, Dose 1 — DRUG
  Leflutrozole, Dose 1 once weekly for 16 weeks
• Leflutrozole, Dose 2 — DRUG
  Leflutrozole, Dose 2 once weekly for 16 weeks
• Leflutrozole, Dose 3 — DRUG
  Leflutrozole, Dose 3 once weekly for 16 weeks
• Placebo — DRUG
  Placebo once weekly for 16 weeks

Study Details

The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men. 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.

Key Dates

Start date

Jun 27, 2025

Status verified

Feb 2026

Primary completion

Jul 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Leflutrozole, 0.05 mg
  Leflutrozole, 0.05 mg, oral capsule, once weekly for 16 weeks
• Experimental: Leflutrozole, 0.1 mg
  Leflutrozole, 0.1 mg, oral capsule, once weekly for 16 weeks
• Experimental: Leflutrozole, 0.3 mg
  Leflutrozole, 0.3 mg, oral capsule, once weekly for 16 weeks
• Placebo Comparator: Placebo
  Placebo, oral capsule, once weekly for 16 weeks

Primary Outcome Measure

Change in total motile sperm count (TMSC) after 16 weeks of treatment. [ Time Frame: From baseline to the end of treatment at 16 weeks. ]

Central Contacts

• Public Disclosure
  +45 32225466
  [email protected]

Locations (4)

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