NCT06993155 · ReproNovo Aps
A Clinical Trial Evaluating the Efficacy and Safety of Leflutrozole on Testicular Function in Men With Hypogonadotropic Hypogonadism
(ETNA)
What this study is about
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 and fertility. It will also study the safety of leflutrozole.
View original scientific description
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 and fertility. It will also study the safety of leflutrozole.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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
- 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 th
Where
- North Hollywood, California
- Pomona, California
- Garden City, New York
- Middleburg Heights, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations