RecruitingPhase IIIInterventional

ESTEEM: A clinical trial testing whether testosterone can help improve the quality of life during menopause

The ESTEEM study is exploring if adding a testosterone cream to your current Hormone Replacement Therapy (HRT) can improve various menopause symptoms for women in the UK. Many women still experience issues like poor sleep, brain fog, headaches, hot flushes, low mood, and low energy, even while on HRT. While testosterone is used for sexual function, its wider effects are less clear. This important study aims to understand if testosterone can help with these other symptoms and to look at any possible side effects, such as acne or hair growth. The goal is to provide evidence that could improve future NHS care for women going through menopause.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Cardiff University

Enrolment target

416

Start

01 Jun 2026

Estimated completion

30 Nov 2027

Medical condition: Menopause Medical condition in lay language: Menopause Therapeutic areas: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

What is this study about?

The ESTEEM study is an important research project looking into menopause symptoms. Many women in the UK experience a wide range of challenging symptoms during menopause, such as trouble sleeping, 'brain fog' (difficulty thinking clearly), headaches, hot flushes, low mood, and feeling tired all the time. While Hormone Replacement Therapy (HRT) is a very effective treatment, it doesn't always completely get rid of all these problems for everyone.

This study wants to find out if adding a special testosterone cream to your usual HRT could help make these ongoing symptoms better. We already know that testosterone can help with sexual function in post-menopausal women, but we don't fully understand its effects on these other common menopause symptoms. By studying this, the ESTEEM trial hopes to gather strong evidence that could help guide future NHS treatments, offering more options for women to feel better.

It's also really important to understand any possible side effects, like acne or increased hair growth, so the study will carefully check for these. The aim is to get a full picture of both the benefits and potential downsides of using testosterone in this way. This research could make a real difference to how women's menopause symptoms are managed in the future.

Key takeaways

Tests if testosterone helps with menopause symptoms not eased by HRT.
Aims to improve future NHS care for menopausal women.
Participants will use a cream (testosterone or 'dummy') for 12 months.
Involves online questionnaires and blood tests.
Monitoring for side effects like acne or hair growth.
Open to women on HRT who still have symptoms.

Who may be eligible?

This study is looking for women in the UK who are currently going through perimenopause or have already gone through menopause. You must already be using standard HRT for at least six months and still be experiencing some menopause symptoms, even with your HRT.

You cannot take part if you have recently used testosterone or certain other hormone medicines within the last six months. Also, if your only menopause symptom is related to sexual function, this study might not be for you. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period cannot participate. There are also restrictions if you have certain health conditions like active cancer or severe kidney problems, or if you are allergic to almonds.

Mainly, we're looking for women who are assigned female at birth, are over 45 years old, and are happy to stay on their current HRT, attend blood tests, and complete online questionnaires for 12 months.

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 in the UK, over 45, who was assigned female at birth?
Are you currently taking standard HRT and have been for at least 6 months?
Do you still experience menopause symptoms even with your HRT?
Have you *not* used testosterone or certain hormone medications in the last 6 months?
Are you able and willing to complete online surveys and have occasional blood tests for 12 months?
Are you *not* pregnant, breastfeeding, or planning to get pregnant during the next year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to use either the testosterone cream or a cream that looks identical but doesn't contain any active medicine (a 'placebo'). You will apply this cream every day for 12 months, in addition to your usual HRT. Neither you nor your doctor will know which cream you are using, which helps us get unbiased results.

Throughout the 12 months, you'll be asked to complete online questionnaires about your symptoms and how you're feeling. These will be done at the start, then after 3, 6, and 12 months. You will also need to have blood tests at these same time points to make sure you're safe and to check hormone levels. Some participants and healthcare staff will also be invited for interviews to share their experiences and opinions. The study will run for a total of 12 months for each participant.

Potential risks and benefits

By taking part, you'll be helping researchers understand whether testosterone can improve menopause symptoms that HRT might not fully address, such as sleep problems, 'brain fog,' or low energy. This valuable information could lead to better NHS care for women in the future. While some women might notice their own symptoms improving, this isn't guaranteed for everyone. Like all medicines, testosterone cream can have side effects, which might include acne, oily skin, or increased hair growth. Very rarely, more serious issues can occur, but the study includes regular safety checks and medical follow-ups to monitor your health closely. Participating also requires a time commitment for blood tests, applying the cream daily, and filling out questionnaires. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Cardiff University
Approximate
Cardiff, Wales

Common questions

What is the main goal of the ESTEEM study?

The study aims to see if adding testosterone cream to regular HRT can improve a wider range of menopause symptoms, beyond just sexual function.

Will I know if I'm getting testosterone or a dummy cream?

No, neither you nor your doctor will know if you're getting the testosterone cream or a 'placebo' (a cream with no active medicine). This helps ensure fair results.

How long will I be involved in the study?

Each participant will take part in the study for 12 months, during which they will use the cream and complete assessments.

What kind of side effects might I experience?

Possible side effects could include acne, oily skin, or increased hair growth. The study will monitor you closely for these and any other issues.

Will this study guarantee my symptoms will get better?

No, while some participants may see an improvement, it's not guaranteed. The study's main goal is to gather information for future care.

How to find out more

Martina Svobodova

esteem@cardiff.ac.uk +44 (0)29 20687463 ext 7463 Official trial record

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