Medical condition: Menopause Medical condition in lay language: Menopause Therapeutic areas: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] Urological and Genital Diseases
Conditions
Interventions
• Arm 1 (Intervention): AndroFeme® 1% testosterone cream, transdermal route. The intervention dose uses two pumps (each delivering 0.5 g of 1% testosterone gel, equivalent to 5 mg testosterone per day
Sponsors
Cardiff University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women receiving standard HRT for at least 6 months who remain symptomatic 2. Willing to stay on current standard HRT for duration of trial 3. Able/willing to provide informed consent, including proof of ID 4. At any stage in perimenopause or menopause, including those with Premature Ovarian Insufficiency and medical/surgical menopause already taking standard HRT 5. Able to receive transdermal testosterone 6. Able/willing to adhere to a 12-month follow-up (including regular use of app throughout the trial participation) 7. Able/willing to have blood tests at baseline, 3, 6 and 12 months and as necessary 8. Individuals assigned female sex at birth who are aged > 45 years at the time of consent
Exclusion criteria
Exclusion criteria: 1. Women with altered sexual function as their only symptom attributed to the menopause. 2. High baseline testosterone level outside the pre-menopausal physiological range (above 2.6 nmol/l by immunoassay) 3. Allergy to almonds 4. Pregnant, breastfeeding, planning to become pregnant during the study period, or of childbearing potential and not using a protocol-approved method of contraception. 5. Active malignancy or treatment for malignancy (<6/12); known or suspected carcinoma of the breast; known or suspected androgen-dependent neoplasia 6. Women with nephrotic syndrome 7. History of hypercalcaemia 8. Involvement in another clinical trial for investigational medicinal product (CTIMP) at the time of consent 9. Androgen treatment (testosterone or tibolone) or antiandrogen therapy within the past 6 months (eg. Spironolactone, finasteride, minoxidil, cyproterone) 10. Women who are also using; oral anticoagulants, corticosteroids or adrenocorticotropic hormone (ACTH), oxyphenbutazone, bupropion, ciclosporin, conjugated equine estrogens and any oral contraception containing an estrogenic steroid hormone 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menopause-related quality of life measured using the Menopause-Specific Quality of Life-Intervention (MENQOL-I) questionnaire. Summary scores will be assessed over time, incorporating 3-, 6- and 12-month responses | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline, 3, 6 and 12 months, unless stated: 1. Menopause-related quality of life measured using the MENQOL-I questionnaire (individual domains: vasomotor, psychosocial, physical functioning, sexual; plus total summary score) 2. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) 3. Everyday memory performance measured using the Everyday Memory Questionnaire – Revised (EMQ-R) 4. Depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) 5. Anxiety symptoms measured using the Generalised Anxiety Disorder Assessment (GAD-7) 6. Migraine-related quality of life measured using the Migraine-Specific Quality of Life Questionnaire (MSQoL) 7. Satisfaction with treatment measured using the Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) 8. Health-related quality of life measured using the EQ-5D-5L instrument 9. Capability and wellbeing measured using the ICECAP-A instrument 10. Healthcare resource use measured using a trial-specific resource-use questionnaire 11. Body measurements: participants will provide their height and weight (to calculate BMI) and measure waist circumference at home using a simple tape-measure method 12. Adverse events self-reported via the mobile phone Trial App throughout the trial and summarised at 12 months 13. Adherence to treatment measured using participant weekly self-reporting via the mobile phone Trial App and assessed monthly | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactMartina Svobodova
Outcome results
None listed