ESTEEM -Evaluating effectiveness and cost-effectiveness of Testosterone for Menopause QoL (CPMS 58305, IRAS 1008601)

UPDATED - 05/11/2025

STUDY SUMMARY

• Design: Pragmatic, double-blind, placebo-controlled, individually randomised, parallel, superiority trial with internal pilot, process evaluation and economic evaluation

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

• The primary aim of the trial is to establish the effectiveness of testosterone in reducing menopausal symptoms, beyond altered sexual function, in women already receiving standard HRT as measured by a validated tool of menopause-specific quality of life

• Secondary Objectives:

Confirm feasibility of adequate and equitable trial recruitment, retention and data quality in an internal pilot .

Establish the cost-effectiveness of testosterone based on a primary outcome of Quality Adjusted Life Years. 

Assess safety profile and potential harms of testosterone treatment. 

Gain patient consent and link data to allow long-term monitoring of health outcomes using routinely collected data. 

Explore barriers/facilitators amongst service providers and women to future prescribing and uptake of testosterone. 

Work with lay research partners to design, deliver and report a trial that meets the needs of all women who may experience menopausal symptoms.

INCLUSION CRITERIA

• Women receiving standard HRT for at least 6 months who remain symptomatic.

• Willing to stay on current standard HRT for duration of trial .

• Able/willing to provide informed consent, or their legal representative is willing to provide informed consent. 

• At any stage in perimenopause or menopause, including those with Premature Ovarian Insufficiency and medical/surgical menopause already taking standard HRT. 

• Able to receive transdermal testosterone. 

• Able/willing to adhere to a 12-month follow-up .

• Able/willing to have blood tests.

• Individuals assigned female sex at birth who are aged > 45 years at the time of consent.

EXCUION CRITERIA

• Women with altered sexual function as their only menopausal symptom. 

• High baseline testosterone level outside the pre-menopausal physiological range (0.5-2.6 nmol/l by immunoassay).

• Allergy to almonds. 

• Pregnant or breast feeding or planning pregnancy.

• Active malignancy or treatment for malignancy (<6/12); known or suspected carcinoma of the breast; known or suspected androgen-dependent neoplasia.

• Women with nephrotic syndrome.

• History of hypercalcaemia. 

• Involvement in another clinical trial for investigational medicinal product (CTIMP).

• Androgen treatment (testosterone or tibolone) or antiandrogen therapy within the past 6 months (eg. Spironolactone, finasteride, minoxidil, cyproterone).

• Women who are also using; oral anticoagulants, corticosteroids or adrenocorticotropic hormone (ACTH), oxyphenbutazone, bupropion, ciclosporin, conjugated equine estrogens and oral contraceptives containing ethinylestradiol.

• Less than 1 month use of complementary and/or prescribable non-hormonal alternatives to HRT, which have been shown in trial to be of benefit, such as Fezolinetant, Oxybutinin, Selective Serotonin Reuptake Inhibitor (SSRI), or SNRI/SSRI, Gabapentin, Pregabalin, Clonidine, St Johns Wort, Isoflavones and Black Cohosh.

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

EMIS: Jodie Button – jodie.button@nihr.ac.uk 

SystmOne: VACANT

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