Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Pharmacodynamics and safety of human recombinant luteinising hormone in hypogonadotropic hypogonadal men

This research study is for men who have a medical condition known as hypogonadotropic hypogonadism. This just means their body isn't making enough of a hormone called testosterone because of a problem with signals from the brain. The study is testing a new medicine called lutropin alfa. Researchers want to understand how this medicine works in the body and if it can help increase testosterone levels. They also want to check if it's safe and doesn't cause too many side effects. This is a combined Phase II and Phase III study, which means it's looking at both how well the medicine works and how safe it is over a longer period, involving a larger group of people.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Department Of Biomedical Metabolic And Neural Sciences

Enrolment target

Start

27 Jan 2025

Hypogonadotropic hypogonadism

What is this study about?

This study is investigating a new medication called lutropin alfa, which is a man-made version of a natural hormone called luteinising hormone (LH). This hormone plays a key role in men's bodies by telling the testicles to produce testosterone. The study is specifically for men who have a condition called hypogonadotropic hypogonadism, where their body doesn't produce enough LH, leading to low testosterone levels.

Low testosterone can cause various symptoms, such as tiredness, reduced sex drive, and difficulty building muscle. By giving men with this condition lutropin alfa, researchers hope to see if it can successfully boost their testosterone levels to a healthier range. They will be carefully measuring the amount of testosterone in the participants' blood to see how effective the medicine is.

Alongside checking if the medicine works, a very important part of this study is to make sure lutropin alfa is safe. Researchers will be closely monitoring participants for any side effects and overall health changes. The goal is to gather enough information to understand if this new treatment could be a good option for men living with hypogonadotropic hypogonadism.

Key takeaways

This study is testing a new medicine for low testosterone caused by a specific hormone problem.
It aims to see if the medicine can increase testosterone safely.
Only men aged 18 and over with 'hypogonadotropic hypogonadism' can join.
Participation involves regular clinic visits for checks, blood tests, and medicine.
You can leave the study at any time if you change your mind.

Who may be eligible?

This study is looking for men aged 18 years and older. There is no upper age limit, so men of all adult ages are welcome to be considered.

The main requirement for joining this study is that you must have a medical condition called hypogonadotropic hypogonadism. This means that your body isn't producing enough of certain hormones from your brain that tell your testicles to make testosterone.

To find out if you have this condition and if this study might be right for you, you would need to have a medical check-up with the study doctors. They will perform tests and ask about your health history to see if you meet all the specific criteria for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Are you 18 years old or older?
Have you been diagnosed with hypogonadotropic hypogonadism?
Are you willing to attend regular clinic visits and have blood tests?
Are you able to follow instructions for taking medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study medicine, lutropin alfa, which will be carefully explained to you. You'll have regular visits to the clinic so that the study team can monitor your health and how the medicine is affecting you. These visits will involve blood tests to check your testosterone levels and other important markers, as well as physical examinations.

The study team will also ask you questions about how you are feeling and any side effects you might experience. They will provide clear instructions on how to take the medicine and what to do if you have any concerns. The total length of your participation will depend on the specific design of this combined Phase II and III study, and this will be fully explained to you before you agree to take part.

Potential risks and benefits

Participating in this study might offer you a potential benefit by improving your testosterone levels and potentially easing symptoms related to low testosterone. However, like all medicines, lutropin alfa might cause some side effects, which will be fully explained to you by the study team. There might also be benefits to future patients as the study helps us learn more about this condition and its treatment. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is hypogonadotropic hypogonadism?

It's a condition where your body doesn't make enough testosterone because of a signalling problem from the brain.

What is lutropin alfa?

It's a man-made version of a natural hormone that tells your body to make testosterone.

Why is this study being done?

To see if lutropin alfa can safely and effectively increase testosterone levels in men with this condition.

Will I get the actual medicine or a dummy pill?

The study doctors will explain this to you, as some studies compare the new medicine to a dummy pill or usual care.

How long will I be in the study?

The exact duration will be explained by the study team, as it varies depending on the study design.