Quick Update for Healthcare Professionals on Topical Testosterone Replacement Therapy for Menopausal Women
Key Points
- 🔍 Check Shared Care Status:
- Verify if testosterone replacement is a shared care drug in your area. Typically initiated by menopause clinics.
- 💼 Primary Care Responsibilities:
- Refer patients to menopause clinic for assessment.
- Contact specialists if concerns arise about shared care arrangements.
- Report serious adverse reactions to MHRA and the referring specialist.
- Continue prescribing as advised by the specialist and monitor as required.
- Inform the specialist if the patient discontinues treatment or if there are any concerns.
Patient Selection and Treatment
- Indication: For menopausal women with loss of libido despite conventional HRT.
- Contraindications: Pregnancy, breastfeeding, active liver disease, hormone-sensitive breast cancer, competitive athletes, high baseline testosterone levels, hypersensitivity.
- Side Effects: May include increased body hair, acne, voice deepening, and clitoral enlargement. Contact the specialist if these occur.
Monitoring
- Specialist: Monitor total serum testosterone before and during treatment, and adjust as necessary.
- Primary Care: Annual monitoring of testosterone levels, symptoms, and side effects. Ensure levels remain within normal physiological range.
Additional Information
- Application Instructions:
- Apply testosterone with clean hands to clean, dry skin on the lower abdomen or upper thighs.
- Wash hands immediately after application.
- Do not cover the skin for 3-5 minutes until dry.
- Testogel® Sachet: Do not wash the site for 1 hour.
- Testim® Gel: Do not wash the site for at least 6 hours.
- Testogel® Pump Dispenser: Do not wash the site for 2 hours.
- Tostran® Pump: Do not wash the site for at least 2 hours.
- Precautions:
- Avoid skin-to-skin contact with the application site to prevent testosterone transfer, especially to pregnant women and children.
- Reduce transfer risk by washing hands after application, covering the site with clothes, or washing the site with soap and water after the recommended time.
- MHRA Drug Safety Update: Inform patients about the risk of transfer, possible adverse effects, and precautions to minimize risk (25 Jan 2023).
- Note: The HRT prepayment certificate, introduced on 1 April 2023, does not apply to transdermal testosterone products. It only applies to products licensed for HRT.
Resources
- NICE Guidance: NICE NG23
- British Menopause Society: Testosterone Replacement
- Achillli C et al. Efficacy and safety of transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder; a systematic review and meta-analysis. Fertil Steril 2017; 107(2):475-482
- Barber RJ, Panay N, Fenton A, International Menopause Society (IMS) writing group. 2016 IMS Recommendations on women’s midlife health and hormone therapy. Climacteric. 2016; 19(2):109-150
- Islam RM et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of RCT data. Lancet 2019; 7 (10):754-766
- NICE NG23: Menopause Diagnosis and management November 2015 updated December 2019 www.nice.org.uk/guidance/ng23
- Full details of prescribing information on topical testosterone products is given in the manufacturers summary of product characteristics (SPCs), available from www.medicines.org.uk ; however, note these refer to the licensed use in male hypogonadism.
