Standard operating procedure

Testosterone Initiation & Monitoring SOP

The exact steps for assessing, starting, prescribing, monitoring, continuing and stopping transdermal testosterone for a patient with hypoactive sexual desire disorder in the menopause, with the blood results and clinical findings that trigger each action

For Women's Health & Menopause ClinicRef BS-WOM-SOP-004See a sample (PDF) →
£29.99
One-off purchase · no VAT · instant download
  • Instant download after checkout
  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Equipment, systems and information required
  • 6. Eligibility gate
  • 7. Contraindications and cautions
  • 8. Consent, information sharing and counselling
  • 9. Prescribing and initiation
  • 10. Monitoring schedule
  • 11. Adverse effects and stopping
  • 12. Safety netting and patient information
  • 13. Records
  • 14. Training and competence
  • 15. Monitoring and audit
  • 16. Related documents
  • 17. Review and version control
  • 18. Disclaimer

CQC fundamental standard

Regulation 15 (Premises and equipment)
This document is written to evidence that standard. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

Legislation & standards it maps to

  • Misuse of Drugs Regulations 2001, in particular Schedule 4 Part 2 (anabolic steroids, including testosterone), regulation 15 (form of prescriptions) and regulation 16 (provisions as to supply on prescription).
  • Human Medicines Regulations 2012, in particular regulation 217 (requirements for prescriptions for prescription only medicines) and regulation 284 (prohibition of advertising prescription only medicines to the public).
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, in particular Regulation 9 (Person-centred care), Regulation 11 (Need for consent), Regulation 12 (Safe care and treatment), Regulation 17 (Good governance) and Regulation 20 (Duty of candour).
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including the guidance on remote prescribing, on prescribing unlicensed medicines and on controlled drugs and other medicines where additional safeguards are needed.
  • GMC, Remote consultations guidance and decision flowchart.
  • British Menopause Society, Tool for Clinicians: Testosterone replacement in menopause (reviewed May 2026).
  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • Medicines and Healthcare products Regulatory Agency, Drug Safety Update: Off-label or unlicensed use of medicines: prescribers' responsibilities; and the Yellow Card scheme.
  • Equality Act 2010.
  • UK General Data Protection Regulation and Data Protection Act 2018; Records Management Code of Practice (2023).
  • Care Quality Commission (CQC) assessment framework: the five key questions (safe, effective, caring, responsive and well-led) and the quality statements of the single assessment framework, and the sector-specific framework for primary care and community services when it replaces them.

Who it applies to

All prescribing clinicians (whether registered with the General Medical Council, the Nursing and Midwifery Council or the General Pharmaceutical Council), the Clinical Lead, the Registered Manager, and administrative and patient-support staff involved in booking, recall and prescription processing at [Organisation Name], including self-employed and locum clinicians and staff working remotely

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

AndroFeme
A 1% testosterone cream made for women. It has a United Kingdom licence for postmenopausal women with low sexual desire, but supply of the licensed pack is still being established.
Androgenic effects
Unwanted male-type effects of too much testosterone, such as acne, extra hair growth, a deeper voice or an enlarged clitoris.
Biopsychosocial assessment
Looking at physical, emotional, relationship and medication causes of a problem together.
British Menopause Society (BMS)
The United Kingdom professional society for healthcare professionals working in menopause care, which publishes practical prescribing tools.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Controlled drug (CD)
A medicine with extra legal controls because it can be misused. Testosterone is in Schedule 4 Part 2.
Data Protection Act 2018
The United Kingdom law, alongside the UK GDPR, on how personal information must be handled.
Duty of candour
The legal duty to be open and honest with a patient when something goes wrong that causes, or could cause, significant harm.
Equality Act 2010
The law protecting people from discrimination, including because of sex or gender reassignment.
General Medical Council (GMC)
The regulator of doctors in the United Kingdom, which sets prescribing standards.
General Pharmaceutical Council (GPhC)
The regulator of pharmacists and pharmacies in Great Britain.
General practitioner (GP)
The patient's family doctor.
Genitourinary syndrome of the menopause (GSM)
Vaginal dryness, soreness, painful sex and urinary symptoms caused by low oestrogen.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards registered care providers must meet.
Hormone replacement therapy (HRT)
Medicines that replace oestrogen, and usually progestogen, to relieve menopause symptoms.
Human Medicines Regulations 2012
The main United Kingdom law on licensing, prescribing, supplying and advertising medicines.
Hypoactive sexual desire disorder (HSDD)
Persistently low sexual desire that causes distress.
Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
A highly accurate laboratory method for measuring small amounts of hormones in blood.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom regulator of medicines and medical devices.
Misuse of Drugs Regulations 2001
The law setting out how controlled drugs are prescribed, supplied, stored and recorded, grouped into Schedules.
National Institute for Health and Care Excellence (NICE)
The body that publishes national evidence-based guidance for health care in England.
NICE guideline NG23
The national guideline Menopause: identification and management, which recommends a trial of HRT before testosterone is considered.
Nursing and Midwifery Council (NMC)
The regulator of nurses and midwives in the United Kingdom.
Off-label use
Using a licensed medicine in a way its licence does not cover, such as a different patient group or dose.
Premature ovarian insufficiency (POI)
Loss of normal ovarian function before the age of 40.
Prescription-only medicine
A medicine that can only be supplied against a valid prescription.
Records Management Code of Practice (2023)
National guidance on how long health and care records should be kept and how they are managed.
Regulation 284
The part of the Human Medicines Regulations 2012 that bans advertising prescription-only medicines to the public.
Schedule 4 Part 2
The group of controlled drugs, mainly anabolic steroids such as testosterone, with lighter controls than Schedules 2 and 3.
Selective serotonin reuptake inhibitors (SSRIs)
A common group of antidepressants that can reduce sexual desire.
Serotonin and noradrenaline reuptake inhibitors (SNRIs)
Another group of antidepressants that can reduce sexual desire.
Sex hormone-binding globulin (SHBG)
A blood protein that carries sex hormones and affects how much testosterone is available to the body.
Special (unlicensed medicine)
A medicine without a United Kingdom licence, made or imported to meet an individual patient's need.
Standard Operating Procedure (SOP)
A written step-by-step instruction for carrying out a task consistently and safely.
Summary of Product Characteristics (SmPC)
The official document describing how a licensed medicine should be used.
Therapeutic use exemption (TUE)
Permission for an athlete to use a banned substance for a genuine medical need.
Total testosterone
The full amount of testosterone in the blood, used to monitor treatment.
Transdermal
Absorbed through the skin, as with a gel, cream or patch.
UK Anti-Doping (UKAD)
The national organisation that runs anti-doping rules in United Kingdom sport.
UK General Data Protection Regulation (UK GDPR)
The United Kingdom's main data protection law.
World Anti-Doping Agency (WADA)
The international body that publishes the list of substances banned in sport.
Yellow Card scheme
The MHRA system for reporting suspected side effects of medicines, open to professionals and patients.

How it works

  1. Buy securely with Stripe - instant, no VAT, no account needed.
  2. Download your editable Word file from the link we email you straight away.
  3. Complete the placeholders for your service, then have it approved before use.
  4. Add the optional updates subscription and we keep it current as guidance changes.

Related documents

PolicyWomen's Health Scope of Service Policy£44.99
PolicyMenopause Assessment & Diagnosis Policy£44.99
PolicyHRT Prescribing Policy£44.99
PolicyTestosterone Prescribing in Women Policy£44.99

Need the whole set?

Buy the full Women's Health & Menopause Clinic pack and save versus buying documents individually.

View the Women's Health & Menopause Clinic pack →