Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase 1 study to investigate the pharmacokinetic profile and safety of 3 testosterone gel formulations in postmenopausal female participants.

This study is being carried out to learn more about new testosterone gels for women who have gone through menopause. For a while, testosterone has been used to help women with certain menopausal symptoms, but there isn't a specific licensed product for women in the UK. This study is the very first step to see how these three new gel formulations are taken in by the body (this is called pharmacokinetics) and to check if they are safe. Participants won't have any specific medical conditions, and will be healthy women who have completed menopause. The results will help researchers decide if these gels should be studied further for potential future use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Chemo Research S.L.

Enrolment target

Start

02 Dec 2025

No medical conditions.

What is this study about?

Imagine you're trying a new type of cream to help your skin. This study is a bit like that, but for testosterone gels for women who have finished menopause. Testosterone is a hormone naturally made by the body. Sometimes, after menopause, women might have lower levels of testosterone, which can lead to certain symptoms. While testosterone is used by some doctors for women, there isn't a specific gel or cream made for women that is officially approved in the UK yet.

This study is a very early step, often called a Phase 1 study. It's like testing a new recipe for the first time – you want to make sure it tastes good and is safe to eat before you make a big batch. Researchers want to see how the body handles three different types of testosterone gel. They'll be looking at how much testosterone gets into the bloodstream and how long it stays there. This helps them understand which gel might be the most effective and easiest to use.

The main goal is to check for safety. They'll be watching very closely for any side effects or unwanted reactions to the gels. This information is really important because it helps scientists decide if these gels should be studied further in larger groups of women to see if they can help with menopausal symptoms.

Key takeaways

This study is testing three new testosterone gels for postmenopausal women.
The main goals are to check safety and how the body absorbs the gels.
It's a very early-stage study, so direct personal benefits for participants are not guaranteed.
Participants must be healthy women who have completed menopause.
Your involvement could help develop new treatment options in the future.

Who may be eligible?

To join this study, you need to be a woman who has gone through menopause. This means your periods have stopped completely for at least 12 months, and you're not using any hormone replacement therapy that could affect your hormone levels.

You also need to be at least 18 years old. The most important thing is that you should be in good general health. This means you don't have any serious medical conditions that could make it unsafe for you to take part or affect the study results.

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 woman who has gone through menopause (no periods for 12+ months)?
Are you at least 18 years old?
Are you generally in good health?
Are you currently not using any hormone replacement therapy or other treatments that could affect your hormone levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given one of the three different testosterone gels to use. Researchers will need to take blood samples regularly to measure how much testosterone is in your body and how it's being processed. You'll also have regular check-ups to make sure you're feeling well and to look for any possible side effects. The exact number of visits, how long you'll use the gel, and the total duration of your involvement will be clearly explained by the study team. They'll also let you know how long any follow-up appointments will last after you stop using the gel.

Potential risks and benefits

It's important to understand that this is an early-stage study, so the direct personal benefit might not be clear. However, you would be helping to advance medical knowledge and potentially contribute to developing new treatment options for other women in the future. As with any medication, there are potential risks, including side effects from the testosterone gel, such as skin irritation where the gel is applied, or other hormonal changes. The research team will carefully monitor you for any such effects. 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
Spain

Common questions

What does a 'Phase 1' study mean?

A Phase 1 study is the very first step in testing a new treatment in people. It mainly checks if the treatment is safe and how the body handles it.

What is 'pharmacokinetics'?

This is a scientific term that means how the body absorbs, processes, and gets rid of a medicine. In this study, it's about how the testosterone gel gets into your body and leaves it.

Will this study help with my menopausal symptoms?

This study is focused on safety and how the gels work in the body, not directly on treating symptoms. Any benefits to your symptoms would be a side observation at this early stage.

Are there any costs involved for me to participate?

No, you should not have to pay to participate in a clinical study. All study-related care and medication will be provided.

Can I continue with my usual medications if I join?

The study team will review all your current medications to ensure they don't interfere with the study. Some medications might mean you can't take part.