Can adding testosterone to standard Hormone Replacement Therapy (HRT) reduce menopausal symptoms beyond improved sex drive?

A new study aims to show whether testosterone has health, social and financial benefits in menopausal women.

Researchers in Wales aim to establish for the first time the impact of 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 ESTEEM 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. All women recruited will be assigned equally to receive either testosterone or placebo.

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.

Women in the ESTEEM study will report their current symptoms when they join the study, and then at 3, 6, and 12 months. The ESTEEM team 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. The ESTEEM team will also look at physical functioning including muscle and joint aches and pains, brain fog, mental clarity, and energy levels. The ESTEEM team will measure costs to women due to their symptoms such as time taken off work and costs to health and social services.

The ESTEEM study is being run from the Centre for Trials Research (CTR) at Cardiff University, and is led by Professor Mike Robling and Dr Helen Munro. Professor Mike Robling is co-director of the CTR, a UKCRC registered clinical trials unit. Dr Helen Munro is recipient of a Research Time Award from Welsh Government via Health and Care Research Wales, and is a consultant specialising in Sexual and Reproductive care, based at Hywel Dda University Health Board.

“We hope this will be the study to show whether testosterone will bring important benefits for women or otherwise with a robust randomised controlled trial. Should clear benefits be shown in the study, it will help contribute to reducing healthcare inequalities in health across the UK and improving the well-being of many women.”
- Professor Mike Robling, co-director of the Centre for Trials Research

“As a Consultant in Sexual and Reproductive Healthcare, specialising in the Menopause, I am delighted to be a co-lead on this study. We hope ESTEEM will inform healthcare approaches globally in this key area. We know that testosterone has benefits to women with regard to sexual function, and we urgently need to understand the other potential benefits and any risks to treatment.”
- Dr Helen Munro, Hywel Dda University Health Board

Collaborating partners on the study include academics from the Swansea Centre for Health Economics. The study team are also working with two public organisations – the Talking Trials community partnership and Fair Treatment for Women in Wales. The study is funded by the National Institute for Heath and Care Research (NIHR) Health Technology Assessment (HTA) programme and runs for four years, with results expected in 2028. The Centre for Trials Research at Cardiff University is funded by Welsh Government through Health and Care Research Wales.

For enquiries about the study, please email ESTEEM@cardiff.ac.uk

About the National Institute for Health and Care Research (NIHR)

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low-and-middle-income countries is principally funded through UK Aid from the UK government.