A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function in Men With Hypogonadotropic Hypogonadism (Low Serum Testosterone)
NCT ID: NCT06993155
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-06-27
2026-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Leflutrozole, 0.05 mg
Leflutrozole, 0.05 mg, oral capsule, once weekly for 16 weeks
Leflutrozole, Dose 1
Leflutrozole, Dose 1 once weekly for 16 weeks
Leflutrozole, 0.1 mg
Leflutrozole, 0.1 mg, oral capsule, once weekly for 16 weeks
Leflutrozole, Dose 2
Leflutrozole, Dose 2 once weekly for 16 weeks
Leflutrozole, 0.3 mg
Leflutrozole, 0.3 mg, oral capsule, once weekly for 16 weeks
Leflutrozole, Dose 3
Leflutrozole, Dose 3 once weekly for 16 weeks
Placebo
Placebo, oral capsule, once weekly for 16 weeks
Placebo
Placebo once weekly for 16 weeks
Interventions
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Leflutrozole, Dose 1
Leflutrozole, Dose 1 once weekly for 16 weeks
Leflutrozole, Dose 2
Leflutrozole, Dose 2 once weekly for 16 weeks
Leflutrozole, Dose 3
Leflutrozole, Dose 3 once weekly for 16 weeks
Placebo
Placebo once weekly for 16 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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:
1. Compounds with androgenic or estrogenic properties (i.e., agonist or antagonist) or that affect production of sex hormones.
2. 5-α reductase inhibitors, e.g., finasteride and dutasteride.
3. Fertility drugs, including clomiphene, FSH, hMG and hCG preparations.
4. Growth hormone.
5. Opioid-receptor antagonists, e.g., naloxone and long-acting opioids.
6. Selective α-adrenergic-receptor antagonists (alpha blockers).
7. Topical or systemic testosterone replacement therapy (TRT).
8. 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.
18 Years
49 Years
MALE
No
Sponsors
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ReproNovo Aps
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
ReproNovo Aps
Locations
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ReproNovo Investigational Site
North Hollywood, California, United States
ReproNovo Investigational Site
Garden City, New York, United States
ReproNovo Investigational Site
Middleburg Heights, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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ReproNovo Investigational Site
Role: primary
ReproNovo Investigational Site
Role: primary
ReproNovo Investigational Site
Role: primary
Other Identifiers
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RPN-LFT01
Identifier Type: -
Identifier Source: org_study_id