ESTEEM

Evaluating the clinical and cost-effectivenesS of TEstosteronE to improve Menopause-related quality of life.

The ESTEEM trial aims to find out if adding testosterone to standard Hormone Replacement Therapy (HRT) can reduce menopausal symptoms beyond its effect on sexual function (libido). The ESTEEM trial will establish for the first time the impact testosterone on cognition, exercise, motivation and energy levels in menopausal women. Further benefits for women may include improved mood and increased focus in the workplace.

The study is a randomised controlled trial (RCT) funded by the National Institute for Health and Care Research (NIHR). Over 400 menopausal women will be able to self-refer to the study or enrol through their GP practice.

There are around 13 million people who are estimated to be peri or menopausal in the UK. For most women, menopause is a process which can, for some, cause anxiety and distress because of a wide range of symptoms. HRT is currently the most effective and widely used medical treatment for menopausal symptoms but for many women symptoms continue to impact on their lives despite its use.

Testosterone can improve menopause symptoms such as libido. However, we do not know whether other symptoms not well managed by usual HRT can also be improved by adding testosterone. For example, the impact of testosterone on cognition, exercise, motivation and energy levels which may also improve a wider range of important outcomes (for example mood, employment). We also need to identify any possible harms of testosterone to assess whether benefits outweigh any risks (for example aggression, acne, hair growth, cancer).

The ESTEEM trial participants will be patients whose sex assigned at birth was female. We will invite women on HRT but still experiencing menopausal symptoms to register an interest in taking part.  Women will report their current symptoms when they join the study, and then at 3, 6, and 12 months. We will measure whether symptoms important to women improve or get worse using a questionnaire. These symptoms will include hot flushes, night sweats, mood, cognition, relationships, and confidence. We will also look at physical functioning including muscle and joint aches and pains, brain fog, mental clarity, and energy levels. We will measure costs to women due to their symptoms such as time taken off work and costs to health and social services.

We will advertise the trial widely through GP practices, pharmacists and social media. A healthcare professional will contact women registering their interest to see if they are suitable for the trial. A computer programme will put women into one of two groups at random (like tossing a coin). One group will be given testosterone gel. The other group will be given a gel which looks exactly the same as the testosterone one but has no active medication in it. Both groups will use their gels for 12 months and continue their usual HRT treatment. We will ask women’s permission to access their medical records in the future to explore longer-term health outcomes. We will interview some women who decided to take part in the study, some who did not, and some health professionals to find ways to make it easier for women to join the study, stay involved and gain access to testosterone in the future.