Status:
RECRUITING
A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function in Men With Hypogonadotropic Hypogonadism (Low Serum Testosterone)
Lead Sponsor:
ReproNovo Aps
Conditions:
Hypogonadotropic Hypogonadism
Eligibility:
MALE
18-49 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate three doses of the drug leflutrozole on improvement of semen quality in men with hypogonadotropic hypogonadism, a condition that affects hormone levels a...
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 Sex Hormone Binding Globulin within or above normal range at screening.
- 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:
- Compounds with androgenic or estrogenic properties (i.e., agonist or antagonist) or that affect production of sex hormones.
- 5-α reductase inhibitors, e.g., finasteride and dutasteride.
- Fertility drugs, including clomiphene, FSH, hMG and hCG preparations.
- Growth hormone.
- Opioid-receptor antagonists, e.g., naloxone and long-acting opioids.
- Selective α-adrenergic-receptor antagonists (alpha blockers).
- Topical or systemic testosterone replacement therapy (TRT).
- Anabolic steroids.
- 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.
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06993155
Start Date
June 27 2025
End Date
November 1 2026
Last Update
November 13 2025
Active Locations (3)
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1
ReproNovo Investigational Site
North Hollywood, California, United States, 91606
2
ReproNovo Investigational Site
Garden City, New York, United States, 11530
3
ReproNovo Investigational Site
Middleburg Heights, Ohio, United States, 44130