The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Summary
The NIHR is interested in receiving applications for applied health research studies to increase the evidence base for testosterone as a treatment for menopause symptoms beyond altered sexual function. The NIHR recognises that people have diverse gender identities, and in this highlight notice, the word ‘woman’ is used to describe patients or individuals whose sex assigned at birth was female, whether they identify as female, male, or non-binary.
The NIHR HTA Programme is working in partnership with NICE to generate new, high-quality evidence to support the menopause guideline update. This research call has been researched and written in a very short time, on the basis of information from a quick search of relevant sources and databases and consultation with a small number of experts in the field, as well as members of the public.
Background
Menopause is when a woman’s periods stop due to lower hormone levels, usually between the ages of 45 and 55. Perimenopause is the stage before this, when symptoms occur but periods have not yet stopped. Menopause is reached when a woman has not had a period for 12 months. Both perimenopause and menopause can cause symptoms such as mood swings, anxiety, brain fog, hot flushes, reduced sex drive, and vaginal dryness. These symptoms may continue to occur for a number of years after periods have stopped (NHS Menopause, accessed June 2022).
A systematic review andmeta-analysis published in 2019 included 36 randomised controlled trials, totalling 8480 participants. Themeta-analysis showed that compared with a comparator or placebo, testosterone significantly increased sexual function. Some of the studies indicated that testosterone therapy has additional effects, such as increasing bone mineral density, and reducing high-density lipoprotein (HDL) cholesterol. However, there is little evidence on the effects of testosterone therapy on the many other menopausal symptoms (Islam, R.M. et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. The Lancet: Diabetes and Endocrinology, 2019, 7;10:754-766).
Testosterone supplementation is to be considered for menopausal women with low sexual desire ifHRT alone is not effective. This is an off-label use (NICE Guideline Menopause: diagnosis and management, accessed June 2022).
The long-term safety profile of testosterone therapy in postmenopausal women is not clear and this uncertainty is reflected in highly variable prescribing behaviour across the UK.
Specific requirements for this call
The NIHR HTA Programme is inviting research proposals that seek to increase the evidence base for testosterone as a treatment for menopause symptoms beyond altered sexual function. NICE are currently updating their Guideline on Menopause: diagnosis and management [GID-NG10241] and have recently published the scope (February 2022). Through surveillance and scoping, they could not identify any significant new evidence on the use of testosterone for the treatment of menopause symptoms beyond altered sexual function since NG23 was updated in December 2019. The NIHR HTA Programme is interested in receiving applications for research that would address this gap in the evidence base and inform future NICE guidance. There are questions around both the short-term management of symptoms and also the longer-term side effects, safety profile and potential harms. Whilst it is desirable that primary outcomes are measurable at 5 years, applicants are encouraged to include earlier timepoints for reporting interim findings.
How to apply
Research proposals must be within the remit of the Health Technology Assessment Programme. Applicants should note:
- They should justify the importance of their proposed research and its potential impact on patient care
- The HTA Programme will consider a range of research methods and it is open to applicants to define and justify what their proposed outcomes are. Primary outcome measures should focus on the short-term management of symptoms. Longer-term side effects, safety profile and potential harms can be included in secondary outcome measures.
- They should clearly state how their proposed research addresses an explicit evidence gap and how the research adds value to the existing NIHR research portfolio.
- Patient and public involvement should be included within the application and study design.
- The call represents an ongoing area of interest for the NIHR. Following the publication of the Women’s Health Strategy earlier this year, NIHR are keen to fund further research in this priority area. Researchers are encouraged to submit applications in the area of menopause research to NIHR’s researcher-led workstreams.
- Where appropriate, applicants should consider contacting their local Research Design Service or equivalent for support.
Contact information
For commissioning brief queries, please contact htaresearchers@nihr.ac.uk.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted online no later than 1pm, 3 May 2023. Applications will be considered by the HTA Funding Committee at its meeting in July 2023.
Guidance notes and supporting information for HTA Programme applications are available.
Important: Shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in November 2023. Applications received electronically after 1pm on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same Co-Applicant joining more than 1 competing team. There may be unusual circumstances where the same person could be included on more than on application e.g. a lead from a named charity or a unique national expert in a condition.
For such exceptions, (i) each application needs to state the case as to why the same person is included, (ii) the shared Co-Applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their Co-Applicants is part of a competing application and that study details have not been shared.
Should you have any queries please contact us: htagb@nihr.ac.uk.