Could a weekly pill boost sperm count? new trial seeks answers
NCT ID NCT06993155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests three doses of a drug called leflutrozole to see if it can improve semen quality in men with low sperm count and low testosterone. About 200 men aged 18-49 will take either the drug or a placebo once a week for 16 weeks. Researchers will measure changes in sperm count, movement, and shape, and monitor for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 49 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ReproNovo Investigational Site
RECRUITINGNorth Hollywood, California, 91606, United States
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ReproNovo Investigational Site
RECRUITINGPomona, California, 91767, United States
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ReproNovo Investigational Site
RECRUITINGGarden City, New York, 11530, United States
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ReproNovo Investigational Site
RECRUITINGMiddleburg Heights, Ohio, 44130, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Scientists hunt for genes that control puberty
- Can acne drug or hormone shots help men with low sperm count?
- Could a natural hormone restart periods in women with hypothalamic amenorrhea?
- Could a brain hormone fix low sex hormones? small study hints at possibility
- Could a natural hormone restore ovulation in women with hypothalamic amenorrhea?