NCT06993155

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

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Dose-response Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: ReproNovo Aps · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Semen Quality

Interventions

Type	Name	Description
DRUG	Leflutrozole, Dose 1	Leflutrozole, Dose 1 once weekly for 16 weeks
DRUG	Leflutrozole, Dose 2	Leflutrozole, Dose 2 once weekly for 16 weeks
DRUG	Leflutrozole, Dose 3	Leflutrozole, Dose 3 once weekly for 16 weeks
DRUG	Placebo	Placebo once weekly for 16 weeks

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-07-01
• Completion: 2026-11-01
• First posted: 2025-05-28
• Last updated: 2026-02-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study