MedTrace Logo

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

NCT06993155 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-02-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ReproNovo Aps

    lead INDUSTRY

Principal Investigators

  • Medical Director · ReproNovo Aps

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2026-07-31
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993155 on ClinicalTrials.gov