Not yet recruitingPHASE2INTERVENTIONAL

A Dose Ranging Study to Examine TDS-Testosterone 5%

This study is testing a new way to give testosterone to men who naturally produce very little or no testosterone. It uses a pump sprayer to deliver testosterone gel through the skin. Researchers want to see how different doses, from low to high, affect these men. This will help them decide on the best starting doses for bigger, longer studies in the future. The study is taking place in London, UK, and involves checking men's responses to varying amounts of the testosterone gel.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Transdermal Delivery Solutions Corp

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Feb 2027

Hypogonadotropism

What is this study about?

This research study is looking into a new way to give testosterone to men who are not producing enough of this important hormone naturally. This condition is sometimes called hypogonadism. Testosterone plays a big part in men's health, affecting things like energy levels, mood, and muscle strength.

The study involves a special gel with testosterone that you apply to your skin using a pump sprayer. The main goal here isn't to cure the condition, but to understand how different amounts of the testosterone gel affect men. The researchers want to find out what range of doses is effective and safe. They've already done some initial tests to make sure the gel can get testosterone into the body properly.

By carefully testing various doses in this study, the doctors want to figure out the best starting dose for future, larger studies. This will help them design better research in the long run to develop new treatments for men with low testosterone.

Key takeaways

Tests a new testosterone gel applied to the skin.
Aims to find the best starting dose for future studies.
For men aged 18-75 with naturally low testosterone.
Requires regular visits and blood tests in London.
You won't know which dose you are getting.
Contributing to new understanding for men's health.

Who may be eligible?

This study is looking for men aged between 18 and 75 who have been diagnosed with naturally low testosterone levels. To check this, you'll need to have two separate blood tests that confirm your testosterone is below a certain level. You should also be generally fit and healthy, without any serious medical conditions that could affect the study results, and be a non-smoker.

There are some reasons why you might not be able to join. For example, if you have certain heart, liver, kidney, or other serious health problems, or if you've had blood clots in the past. You also can't take part if you've had a recent serious illness, are allergic to testosterone, or are taking certain medications that might interfere with the study. If you have a high reading for PSA (a prostate marker) or other abnormal blood tests, you might also not be eligible.

It's important that you're able and willing to follow all the study instructions, attend all appointments in London, and understand what's involved by reading the information provided.

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 aged between 18 and 75?
Do you have a confirmed diagnosis of low testosterone (checked by blood tests)?
Are you generally healthy and a non-smoker?
Are you able to travel to London for study visits?
Can you follow study instructions, including having regular blood tests?

Answer every question to see your result.

What does participation involve?

If you take part, you'll first have some checks to make sure you're suitable, including blood tests and a health check-up. Once accepted, you'll be one of 48 men in the study. You'll be assigned to one of four groups, and each group will receive different amounts of the testosterone gel. The amount will be adjusted by how many sprays you use. The doses will vary from 10 to 70 milligrams of testosterone.

Throughout the study, you'll need to visit the study site in London for various assessments. This will include having a small, temporary tube (catheter) placed in your arm on two separate occasions so that blood samples can be taken frequently over a period. This helps researchers understand how your body handles the testosterone from the gel. You'll also have other blood tests and check-ups to monitor your health. The total duration of your participation in the study will be explained in detail by the study team.

Potential risks and benefits

Participating in research studies like this means you might not directly benefit, but you'll be contributing to scientific understanding that could help other men in the future. There's a chance the testosterone treatment might help improve your low testosterone symptoms. However, like all medicines, there can be risks. These could include side effects from the testosterone or from the procedures, such as discomfort from blood draws. You will be closely monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Advanced Therapies Centre, The London Clinic
Verified postcode
London, United Kingdom

Common questions

What is hypogonadism?

Hypogonadism means your body doesn't produce enough testosterone, an important male hormone. This can cause symptoms like low energy or changes in mood.

What is a 'pump sprayer' for testosterone?

It's a way to apply testosterone gel directly onto your skin using a pump, similar to how some hand sanitisers or moisturisers are dispensed.

Where does the study take place?

The study is being held in London, UK, at The London Clinic's Advanced Therapies Centre.

Will I get paid to be in the study?

The study information doesn't mention payment, but you should ask the study team about any travel expenses or compensation for your time.

What happens after the study ends?

This study is focused on finding the right dose for future research. While it might help your testosterone levels during the study, it generally doesn't provide long-term treatment after it finishes.

How to find out more

Shern L. Chew, M.D., Ph.D.

sl.chew@thelondonclinic.co.uk 011-44-20 034 6227 Official trial record

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