Ongoing Clinical Trials for Primary Hypogonadism
Currently, there is 1 ongoing clinical trial investigating new treatment options for primary hypogonadism. This trial is being conducted in Italy and focuses on comparing the effects of lutropin alfa with standard hCG treatment in men with hypogonadotropic hypogonadism, particularly examining testosterone level improvements.
Clinical trial locations
- Italy
Study on the Effects and Safety of Lutropin Alfa and hCG in Men with Hypogonadotropic Hypogonadism
This clinical trial investigates hypogonadotropic hypogonadism, a condition where the body doesn’t produce enough sex hormones due to problems with the pituitary gland or hypothalamus. In men, this leads to low testosterone levels, reduced muscle mass, decreased libido, and fertility problems. The study compares a medication called lutropin alfa with the standard treatment, urinary hCG (Gonasi HP), to see which works better at increasing testosterone levels.
Who can participate:
- Adult men diagnosed with hypogonadotropic hypogonadism
- Patients within a specific age range as defined by the study
- Men who are not part of a vulnerable population, meaning they don’t have additional conditions that put them at higher risk
Who cannot participate:
- Women are not eligible for this study
- Men who do not have hypogonadotropic hypogonadism
- Individuals considered part of a vulnerable population who may not be able to give proper informed consent
- People outside the specified age range
What the trial involves:
Participants receive treatment with Luveris, which contains lutropin alfa, a human recombinant luteinising hormone. This medication is given through subcutaneous injections, meaning the medication is injected just under the skin. The study monitors how this treatment affects testosterone levels in the blood over time.
The trial follows a structured approach:
- An initial assessment confirms the diagnosis and establishes baseline testosterone measurements
- Treatment with lutropin alfa begins, with dosage and frequency adjusted based on individual response
- Regular blood tests monitor testosterone levels throughout the study period
- Results are compared with those from men receiving the standard treatment, Gonasi HP (urinary hCG)
Investigational medications:
Luveris contains human recombinant luteinising hormone. It works by stimulating the testes to produce testosterone, mimicking the natural action of luteinising hormone in the body. This medication is being studied to determine if it can effectively increase testosterone levels in men with hypogonadotropic hypogonadism and potentially help with male infertility.
Gonasi HP contains human chorionic gonadotropin (hCG) and serves as the comparison treatment. It acts similarly to luteinising hormone by stimulating testosterone production in the testes. This is the standard treatment currently used for this condition.
The study is expected to continue until May 31, 2025, and aims to provide valuable insights into whether lutropin alfa could be a more effective treatment option for men with this condition. The findings may help doctors better understand how to manage hormone deficiency and related fertility issues in affected men.
Summary
Currently, only one clinical trial is actively recruiting patients with primary hypogonadism, specifically focusing on the hypogonadotropic form of the condition. This trial is being conducted exclusively in Italy and represents an important step in exploring alternative treatment options for men experiencing hormone deficiency.
The study specifically compares a recombinant hormone medication, lutropin alfa (Luveris), with the established standard treatment using urinary hCG (Gonasi HP). Both medications belong to the gonadotropin class and work by stimulating the testes to produce testosterone, but they differ in their composition and how they are manufactured.
The focus on testosterone level improvements reflects the core challenge of treating hypogonadotropic hypogonadism, where insufficient hormone production affects not only physical characteristics and sexual function but also fertility. Results from this trial could help determine whether recombinant hormone therapy offers advantages over traditional urinary-derived treatments in terms of effectiveness, safety, or patient convenience.