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Study on the Effects and Safety of Lutropin Alfa and hCG in Men with Hypogonadotropic Hypogonadism

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as hypogonadotropic hypogonadism, which affects hormone production in men. The study will explore the effects of a treatment using a medication called lutropin alfa, also known as human recombinant luteinising hormone. This medication will be compared to another treatment called urinary hCG (Gonasi HP), which is commonly used for this condition.

The purpose of the study is to understand how lutropin alfa affects the body, particularly in terms of increasing testosterone levels, which is a key hormone in men. Participants will receive different doses of lutropin alfa through subcutaneous injections, which means the medication is injected under the skin. The study will monitor how testosterone levels change in response to the treatment and compare these changes to those seen with the standard treatment, urinary hCG.

The study will take place over a period of time, with participants receiving the treatment and having their testosterone levels checked regularly. This will help researchers determine if lutropin alfa could be a more effective treatment option for men with hypogonadotropic hypogonadism or male infertility. The findings from this study could provide valuable insights into new treatment possibilities for these conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of hypogonadotropic hypogonadism. This condition is characterized by low levels of hormones that stimulate the testes.

  2. Step 2

    Baseline measurements

    Baseline measurements of testosterone serum levels are taken. These levels will be used as a reference to evaluate the effects of the treatment.

  3. Step 3

    Treatment with lutropin alfa

    The treatment involves the administration of lutropin alfa, a human recombinant luteinising hormone. This medication is given through a subcutaneous injection, which means it is injected under the skin.

    The dosage and frequency of the injections are determined by the study protocol and are adjusted based on the response to the treatment.

  4. Step 4

    Comparison with standard treatment

    The response to lutropin alfa is compared with the response to urinary hCG (Gonasi HP), which is the standard treatment. This comparison focuses on changes in testosterone serum levels.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring of testosterone levels is conducted to assess the pharmacodynamics of the treatment. This involves periodic blood tests to measure hormone levels.

    The study continues until the estimated end date of May 31, 2025, unless otherwise specified by the study protocol.

Who can join the trial?

4 criteria

  • The patient must have a condition called hypogonadotropic hypogonadism. This is a medical condition where the body doesn't produce enough hormones needed for sexual development and function.
  • The patient must be male.
  • The patient must be within a specific age range, typically adults.
  • The patient should not be part of a vulnerable population, meaning they should not have additional conditions or circumstances that make them more at risk.

Who cannot join the trial?

4 criteria

  • Women cannot participate in the study. This study is only for men.
  • Individuals who do not have the medical condition called hypogonadotropic hypogonadism cannot participate. This condition involves low levels of hormones that stimulate the testes.
  • People who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may not be able to give informed consent or are at higher risk of harm.
  • Individuals outside the specified age range cannot participate. The study is for a specific age group.
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Investigated drugs

  • Luveris

    is a medication containing human recombinant luteinising hormone (LH). It is being studied to see how it affects testosterone levels in men with a condition called hypogonadotropic hypogonadism (HH). This condition affects hormone production, and the study aims to find out if Luveris can help increase testosterone levels in these men.

  • Gonasi HP

    is a medication that contains human chorionic gonadotropin (hCG). It is commonly used as a standard treatment to stimulate testosterone production in men with HH. In this study, Gonasi HP is used as a comparison to see how well Luveris works in increasing testosterone levels.

What is already known about the treatment

  • Luveris

    This medication is administered through injection and is currently being studied for its effects in men with hypogonadotropic hypogonadism. It is a recombinant form of luteinizing hormone (LH) and is being evaluated for its ability to increase testosterone levels, which is crucial for treating conditions like male infertility. Luveris works by stimulating the testes to produce testosterone, mimicking the natural action of LH in the body. It is classified as a gonadotropin, a type of hormone that plays a key role in reproductive health.

  • Gonasi HP

    This medication is also administered via injection and serves as a standard treatment for hypogonadotropic hypogonadism. It contains human chorionic gonadotropin (hCG), which acts similarly to LH by stimulating testosterone production in the testes. Gonasi HP is used to support male reproductive health by enhancing testosterone levels, which is essential for treating infertility. It is classified under gonadotropins, which are hormones that regulate reproductive functions.

Investigated diseases

Hypogonadotropic hypogonadism – This condition occurs when the body produces insufficient levels of sex hormones due to a problem with the pituitary gland or hypothalamus. It leads to underdeveloped sexual characteristics and can affect fertility. In men, it often results in low testosterone levels, reduced muscle mass, and decreased libido. The condition can be congenital or acquired and may be associated with other hormonal imbalances. It progresses with symptoms related to hormone deficiency, impacting physical and sometimes psychological health. The condition requires medical evaluation to determine the underlying cause and appropriate management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518159-52-02Estimated enrolment1 patientSponsorDepartment Of Biomedical Metabolic And Neural Sciences

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