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Leflutrozole for Improving Semen Quality

This study is testing a drug called leflutrozole to see if it can improve semen quality in men. Researchers want to find out if leflutrozole works and what side effects it might cause. You could be eligible if you are a man aged 18-49 with low testosterone, certain hormone levels, and a low total motile sperm count (the number of moving sperm). Participants will receive one of three doses of leflutrozole or a placebo (an inactive substance) once a week for 16 weeks. The main goal is to see if leflutrozole increases the total motile sperm count after 16 weeks. The current status of this study is unclear, and it plans to enroll 200 participants.

Study design
This is an interventional study comparing three doses of leflutrozole to a placebo. It plans to enroll 200 participants.
What's involved
You would take leflutrozole or a placebo once a week for 16 weeks. You would also visit the clinic every 4 weeks for checkups, provide semen samples, and have blood tests.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured after 16 weeks of treatment, at the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06993155

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

Recruiting
PHASE2Ages 18–49InterventionalTreatment
ReproNovo Aps
~200 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Leflutrozole, Dose 1Leflutrozole, Dose 2Leflutrozole, Dose 3Placebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in total motile sperm count (TMSC) after 16 weeks of treatment.
Measured over From baseline to the end of treatment at 16 weeks.

Conditions

Semen Quality

Explore related trials

InfertilityEstradiolLuteinizing HormoneTestosterone

Where it's being run

4 sites across 3 states
California2
New York1
Ohio1

Study leadership

  • Medical Director · STUDY_DIRECTOR · ReproNovo Aps

Who to contact

Public Disclosure
[email protected]
+45 32225466
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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

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:
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.

What this trial measures

  • Change in total motile sperm count (TMSC) after 16 weeks of treatment.From baseline to the end of treatment at 16 weeks.

    Total motile sperm count will be assessed through semen analysis conducted at specialized andrology laboratories.