Actively Recruiting
A Randomized, Placebo-controlled, Double-blind, Parallel-group, Dose-response Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function
Led by ReproNovo Aps · Updated on 2026-02-27
200
Participants Needed
4
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of the drug leflutrozole on semen quality in men aged 18 to 49 years with low testosterone levels. This phase 2 clinical trial aims to find out whether leflutrozole can improve semen quality and what side effects participants may experience compared to a placebo. The trial is sponsored by ReproNovo Aps and focuses on testicular function and hormone levels. Participants will be randomly assigned to receive one of three doses of leflutrozole (0.05 mg, 0.1 mg, or 0.3 mg) or a placebo. The medication is taken orally once a week for 16 weeks. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Checkups and tests occur every 4 weeks during the treatment period. Men in the trial will provide semen samples to measure sperm count, motility, and other quality markers. Blood tests will monitor hormone levels such as testosterone and estradiol, as well as safety markers including prostate-specific antigen and ECG readings. Questionnaires will assess changes in libido and energy. Researchers will track adverse events throughout the 16 weeks to evaluate safety and effectiveness.
CONDITIONS
Brief Title
A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form prior to any trial activity.
- Male adults aged 18 to 49 years.
- Low serum total testosterone concentration on two occasions.
- Serum estradiol 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 of at least 1.0 mL in two samples.
- Ability to understand and follow the study protocol.
You will not qualify if you...
- Anatomical abnormalities or tumors of the testes.
- Pituitary or hypothalamic disease.
- Prostate disease.
- Use of drugs affecting sex hormones, 5-alpha reductase inhibitors, fertility drugs, growth hormone, opioid antagonists, alpha blockers, testosterone therapy, or anabolic steroids within 6 months before screening.
- Inability to provide required semen samples due to erectile dysfunction or other reasons.
- Participation in another clinical trial within 3 months before screening.
- Significant ECG abnormalities.
- History of thromboembolic disease, grade 3 lower extremity edema, cardiovascular disease, osteoporosis, or fragility fractures.
- Moderate or severe kidney or liver impairment.
- Untreated sleep apnea.
- History of cancer within 5 years.
- Alcohol or drug abuse within 12 months prior to randomization.
- Chronic opioid use or misuse within 12 months prior to randomization.
- Any medical or psychiatric condition that may affect safety or compliance.
- Hypersensitivity to study medication ingredients.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive leflutrozole or placebo once weekly to evaluate effects on testicular function.
Weekly visits for up to 16 weeks
Trial Site Locations
Total: 4 locations
1
ReproNovo Investigational Site
North Hollywood, California, United States, 91606
Actively Recruiting
2
ReproNovo Investigational Site
Pomona, California, United States, 91767
Actively Recruiting
3
ReproNovo Investigational Site
Garden City, New York, United States, 11530
Actively Recruiting
4
ReproNovo Investigational Site
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
Research Team
P
Public Disclosure
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Frequently Asked Questions
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