Register of patient-reported outcomes for menopause management intervention

Annice Mukherjee, Consultant Endocrinologist, Coventry University  – Chair Area 1,2,3 

Paula Briggs, Consultant Reproductive Health, Liverpool – Area 1, 2, 3 

Lynne Robinson, Consultant Gynaecologist, Birmingham – Area 3 Testosterone Lead 

Jennifer Tamblyn, - Clinical Lecturer on Obstetrics and Gynaecology, Birmingham - Area 1,2, 3 

Joyce Harper, Prof Reproductive Science, UCL - Area 1,2,3  

Nick Panay, Prof Reproductive Medicine, Imperial – Area 3 Testosterone 

Paul Simpson, Consultant Gynaecologist, Norfolk and Norwich - Area 3 Testosterone 

Anne Armstrong, Consultant Oncologist Breast, Christie Manchester -  Area 2 

Carlo Palmieri, Prof Oncologist Breast, Clatterbridge Cancer Centre - Area 2 

Richard Simcock, Prof Oncologist Breast, Sussex - Area 2 

Katie Barber, Menopause Specialist GP, Oxford - Area 3 Testosterone  

David Rook, Consultant Gynaecologist, Liverpool - Area 1,2,3 

Mike Savvas, Consultant Gynaecologist, Kings College London – Area 3 Testosterone Lead 

Vikram Talauliker, Consultant Gynaecologist, UCL – Area 1, 2, 3 

Gail Allsopp, GP, Derbyshire - Area 1, 2, 3 

Siggy Joseph, GP, Scotland - Area 1, 2, 3 

Maxine Wheelan, Research Scientists, Coventry -  Area 1 

Ketan Dhataria, Prof Endocrinologist, Norfolk and Norwich - Area 1 

Mark Evans, Prof Endocrinologist, Cambridge - Area 1 

Rebecca Reynold, Prof Endocrinologist, Edinburgh - Area 1 

Helen Turner, Consultant Endocrinologist,  Oxford - Area 4 

Jeremy Tomlinson, Consultant Endocrinologist, Oxford -  Area 4 

Liz O’Riordan, Consultant Breast Surgeon – Retired – Area 2 

Punith Kempagowda, Consultant Endocrinologist, Birmingham – Area 1, 2, 3 

• Liverpool Women’s Hospital
• UCL London
• Norfolk and Norwich
• Oxford Primary and Secondary Care Centres
• Cambridge NHS Trust
• Birmingham NHS Trust
• Birmingham Women's Hospital Edinburgh
• Manchester Secondary Care
• Manchester Christie
• Royal Marsden London
• Imperial College London Clatterbridge Cancer Centre
• Wells Somerset
• Dublin Ireland
• Belfast Trust Northern Ireland
• Cardiff and Vale Wales
• Derbyshire
• Sussex  

Most women worldwide experience menopausal symptoms during the menopause transition or post menopause. Vasomotor symptoms are most pronounced during the first four to seven years but can persist for more than a decade, and genitourinary symptoms tend to be progressive. Although the hallmark symptoms are hot flashes, night sweats, disrupted sleep, and genitourinary discomfort, other common symptoms and conditions are mood fluctuations, cognitive changes, low sexual desire, bone loss, increase in abdominal fat, and adverse changes in metabolic health. These symptoms and signs can occur in any combination or sequence, and the link to menopause may even be elusive. Estrogen based hormonal therapies are the most effective treatments for many of the symptoms and, in the absence of contraindications to treatment, are considered to have a favourable benefit: risk ratio for women below age 60 and within 10 years of the onset of menopause.  

However, research evidence for efficacy and safety of hormone-based menopause treatments have historically been limited to selected groups of women; women with a history of severe obesity, uncontrolled blood pressure, active vascular disease, and any recent cancer diagnosis being excluded from clinical trials. Furthermore, the majority of research has included a predominance of white Caucasian, middle class women. There is sparse evidence for efficacy and safety in women from BAME backgrounds and those experiencing socioeconomic adversity.  

A survey in 2022 by the Fawcett Society found that 46% of women started on hormone replacement therapy (HRT) said their menopause symptoms had not resolved. There is emerging evidence of unconventional dosing regimens for HRT being used due to lack of symptom resolution. Testosterone use with HRT has also increased since the licensing in Australia of a female testosterone product in 2020. However, there is a lack of post-marketing surveillance data on testosterone use in modern cohorts.  

Non-hormonal treatment options for menopause are offered second-line for women who choose not to take HRT, develop side effects with it or for whom it is not safe, such as estrogen receptor positive cancer, which frequently occurs in peri- post menopausel women. Furthermore breast cancer treatments and chemotherapy for other cancers frequently induce menopause in younger pre-menopausal women. However, there are no robust outcome data reporting tolerability and efficacy of treatments or menpause related patient outcomes for such women outside clinical trials.    

There is therefore a clear unmet need to assess outcomes for efficacy and safety of menopause treatments in modern cohorts of women in the menopause transition. Collection of real word data is crucial particularly with respect to women commencing on menopause treatments who may not be represented in historic, or recent clinical trials. 

All areas will include clinical collected data and patient reported outcomes including questionnaires and other reporting tools. There is expected to be multiple outcomes from each area as steering group members produce their own publications on the data collected.  

Area 1 Menopause symptom management, including HRT doses & regimens with focus on diabetes & pre-diabetes; 

1. Data collection to Include vasomotor severity and frequency, treatment impact on quality of life outcomes; Include collection around diabetes diagnosis, treatment, medication. 
2. Data collection on menopause symptoms & HRT use in women with diabetes (dose and regimen).
3. Data collection on use and doses/regimens of HRT to manage menopause symptoms in women with diabetes (efficacy & side effects).

Area 2 Menopause symptom management including HRT doses & regimens with focus on breast cancer; 

1. Data collection of menopause symptoms & management in women undergoing treatment for breast cancer
2. Data collection on systemic HRT use in women with a history of breast cancer (dose and regimen).
3. Data collection on vaginal oestrogen use in women with a history of breast cancer. 
4. Data collection on incidence of new breast cancer episodes in women treated with HRT (dose and regimen).

Area 3 Testosterone Management; 

1. Symptom score before and during treatment including libido, mood, cognition, musculoskeletal symptoms. 
2. Reason for initiation 
3. Were they on oestrogen first and had it been optimised? 
4. Do they have vaginal dryness and has it been treated?
5. Are serum levels being monitored? 
6. Assay used & repeat using LC-TMS if high levels observed via immunoassays 

Area 4 Turners Syndrome Management  

Inclusion/Exclusion Criteria 

Inclusion: 

• All patients seen by the enrolled site will be able to consent patients with a diagnosis of peri- to post- menopause who fit into one or more of the three areas of interest.  
• Area 1 Menopause symptom management, including treatment, doses & regimens with focus on diabetes & pre-diabetes; 
• Area 2 Menopause symptom management including HRT doses & regimens with focus on breast cancer 
• Area 3 Menopause and Testosterone Management 

Exclusion criteria for all areas: 

• Unable to provide informed consent  
• Unable to navigate an English language app on PeopleWith 

The ability to use the patient app to reinforce conversations with their clinicians about their health in consultation visits. 

The ability to track their own health and medications through the app and learn more about themselves and their health in this manner.  

Safety Reporting in the Data Register: 

Regarding safety reporting; the clinical portal and the patient app will have the ability to tag a national yellow card adverse event reporting completion of any adverse drug related events at any time during the project. There will be a notification upon completion by the clinician or patient to prompt the clinician to report these to the drug company per normal protocols.  

https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals