RecruitingPhase IIIInterventional

Best practice for hormonal replacement of puberty in adolescent and young adult men with absent or incomplete puberty

This study is for young men aged 12 to 35 who have a condition where their body doesn't produce enough hormones needed for puberty. This can affect their physical development and ability to have children later on. Currently, many young men in this situation are given testosterone, which helps them develop physically but doesn't fully help their testicles grow or produce sperm. This study will explore whether giving different hormone injections (called gonadotropins) can kickstart full puberty, including proper testicle development and sperm production. The goal is to find the best way to help young men not only develop physically but also improve their chances of having children and their overall well-being as adults. This is a Phase III trial, meaning these treatments have already been tested for safety.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Queen Mary University of London

Enrolment target

108

Start

31 Aug 2025

Estimated completion

31 Mar 2028

Gonadotropin deficiency secondary to hypogonadotropic hypogonadism or pituitary hormone deficiency

What is this study about?

When boys go through puberty, their brain sends special signals, or hormones, to their testicles to help them grow and develop. For some young men, their bodies don't make enough of these hormones. This condition is called gonadotropin deficiency, and it means they might not go through puberty fully without help.

At the moment, the usual treatment for young men with this condition is testosterone. While testosterone helps with physical changes like muscle growth and voice deepening, it doesn't always help the testicles develop properly or produce sperm. This can lead to difficulties having children later in life and might also affect their overall health and how they feel about themselves.

This study wants to find a better way. We're looking at giving young men specific hormone medicines, called gonadotropins, which are the same signals the brain would naturally send. These medicines might help their testicles develop fully, just like they would in a natural puberty. We hope this will not only lead to better physical development but also improve their chances of being able to have children in the future and boost their confidence and well-being. We also want to understand why these treatments might work differently for different people and hear about their experiences.

Key takeaways

A new study for young men (12-35) with hormone deficiency affecting puberty.
Aims to improve physical development and future fertility.
Uses special hormone injections to encourage testicle growth and sperm production.
Could be more effective than current standard testosterone treatment.
Involves regular home injections and clinic visits for up to two years.

Who may be eligible?

This study is looking for young men aged between 12 and 35 years old who have been diagnosed with gonadotropin deficiency. This means your body isn't making enough of the hormones needed for puberty. You need to be willing to take part in the study for at least 18 months.

There are some specific medical details doctors will check to see if you are a good fit. For example, they'll check your hormone levels and the size of your testicles. Your GP will also need to be informed that you're taking part.

You won't be able to join if you are under 12 or over 35, or if you have certain other serious medical conditions, or if your hormone problems are due to other causes like extreme exercise or an eating disorder.

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 male and between 12 and 35 years old?
Have you been told you have gonadotropin deficiency?
Are you able to agree to the study requirements for at least 18 months?
Are you willing for your family doctor (GP) to know you're in the study?
Are you willing to have hormone injections and attend regular check-ups?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be placed into one of four groups, and each group will receive a slightly different combination of special hormone injections. These injections are given just under the skin, usually three times a week for one type of injection and once or twice a week for another. You or an adult will learn how to give these injections at home.

The treatment period will last between 18 and 24 months. During this time, you'll have study visits every 4 to 6 months. These visits will include a physical check-up, blood tests, and scans of your testicles. Once your testicles have reached a certain size, you'll be asked to provide a sperm sample, which can often be done at home. We'll also ask you to fill out questionnaires about your quality of life, and some participants will be asked about their experiences in an interview. You will also have a genetic test done at the beginning of the study.

Potential risks and benefits

There are potential benefits to taking part in this study. You would receive treatment that aims to provide more complete puberty development, including better growth of your testicles, beyond what standard testosterone treatment usually offers. We hope this will lead to improved fertility and overall psychological well-being in adulthood. You can withdraw from the study at any time. The medicines used are generally safe. Any risks are usually minor, such as slight breast development, acne, or a small reaction where the injection is given. These kinds of changes can also happen during natural puberty or with testosterone treatment. The study has been designed with input from patients and aims to minimise any stress, and the assessments are similar to those you'd have during normal NHS care.

Locations (17)

Barts Health NHS Trust
City only
London, United Kingdom
Uclh
Approximate
London, United Kingdom
Great Ormond Street Hospital
Approximate
London, United Kingdom
Hammersmith Hospital
Approximate
London, United Kingdom
St Mary's Hospital
Approximate
London, United Kingdom
Royal Victoria Infirmary
Approximate
Newcastle upon Tyne, United Kingdom
Birmingham Children's Hospital
Approximate
Birmingham, United Kingdom
Alder Hey Hospital
Approximate
Liverpool, United Kingdom
Sheffield Childrens Hospital
City only
Sheffield, United Kingdom
Royal Hospital for Children and Young People
City only
Lothian, United Kingdom
Royal Hospital for Sick Children (Glasgow)
Unverified
Glasgow, United Kingdom
Nottingham Children's Hospital
Unverified
Nottingham, United Kingdom

Common questions

What is gonadotropin deficiency?

It's a condition where your body doesn't produce enough hormones needed to start or complete puberty naturally.

Will this study help me have children in the future?

That's one of the main goals! We hope this treatment will help your testicles develop better, which could improve your chances of producing sperm and having children.

What are the injections like?

They are given just under the skin with a very small, thin needle and are usually not painful. You or a parent/carer will be taught how to give them at home.

How long will I be in the study?

The treatment will last about 18 to 24 months, with follow-up appointments every 4 to 6 months during that time.

What if I decide I don't want to continue?

You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

How to find out more

Shared Team inbox

pingstudy@qmul.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.