Setting up a men’s health and TRT clinic: a playbook for private GPs

The short answer: what it takes to run a TRT clinic responsibly

A GP-led men’s health and testosterone replacement therapy (TRT) service in the UK is safe and defensible if you diagnose testosterone deficiency the way the British Society for Sexual Medicine (BSSM) describes, treat only men who meet that standard, and monitor haematocrit and prostate health on a fixed schedule with written stopping rules. Testosterone is a Schedule 4 Part 2 controlled drug. The GMC says you must not prescribe controlled drugs remotely without access to relevant information from the patient’s records, so plan to share information with the NHS GP from day one. In England you need CQC registration that covers treatment and, if you take blood for a lab, diagnostic and screening procedures. Wales, Scotland and Northern Ireland each have their own regulator. Market the consultation, never the medicine, and expect the NHS GP to decline shared care.

Demand and service models for a men’s health clinic

Interest in testosterone testing has grown quickly, driven largely by direct-to-consumer online clinics and social media. That growth has drawn regulatory attention. In August 2026 the Advertising Standards Authority (ASA) published two upheld rulings against low-testosterone ads, from a wider piece of work using its AI-based Active Ad Monitoring system. One ad claimed that 95% of men with low testosterone are undiagnosed. The other implied that GPs were insufficiently thorough. A GP-led service can offer what many online models do not: an examination, a proper search for secondary causes, and continuity of care.

Common models are:

• Well man check. A one-off health assessment: history, examination, blood pressure, cardiovascular risk score, bloods and a structured conversation about prostate testing. It often brings men in who later need TRT assessment, and it is the safer thing to market.
• Private testosterone test with interpretation. Two correctly timed samples plus a clinician review. Selling a single test result without interpretation is how men end up on treatment they don’t need.
• TRT assessment and treatment programme. Diagnostic work-up, a treatment decision, then a fixed monitoring schedule for the first year and annual reviews after that.
• Membership. A monthly fee that covers reviews and monitoring bloods. It smooths revenue, but make sure the membership never becomes a reason to continue treatment that isn’t helping.

Hybrid delivery works well: an in-person first assessment (examination, blood pressure, testicular and prostate assessment where indicated), with video for results and follow-up. For more on choosing a range of services, see offering health screening packages.

Regulation: CQC, HIW, HIS and RQIA

England: CQC regulated activities

Prescribing prescription-only medicines is part of the regulated activity treatment of disease, disorder or injury. If you take blood and send it to a laboratory, you are also likely to need diagnostic and screening procedures. The CQC’s exemption for blood tests applies only where the sample is not sent to a lab.

The CQC exception for medical practitioners in independent practice is narrow. It does not apply to treatment given remotely by phone, video or email, or to an organisation that employs a range of staff as well as doctors. Most TRT services will therefore need registration. If you are already registered, check that your registered activities and statement of purpose cover the new service before you launch, and apply for a variation if they don’t. See CQC registration for different services.

Wales, Scotland and Northern Ireland

• Wales: Healthcare Inspectorate Wales (HIW) registers independent clinics where doctors regularly provide private medical services. It also registers independent medical agencies, remote or online services with no fixed establishment, where the provider is based in Wales.
• Scotland: Healthcare Improvement Scotland (HIS) treats a private GP service in premises as an independent clinic, which must register.
• Northern Ireland: RQIA registers private doctor services as independent clinics and inspects them at least annually. Its guidance expects a system for contacting the patient’s GP, with consent.

Clinical governance: diagnosing testosterone deficiency

Write a protocol based on the BSSM guidelines (2017, updated in 2023), check it against the current NICE Clinical Knowledge Summaries (CKS) guidance that NHS colleagues use, and audit against it. The product licences say the same thing in a different way: Testogel, Nebido and Sustanon 250 are all licensed for male hypogonadism "when testosterone deficiency has been confirmed by clinical features and biochemical tests". A man with symptoms and a single low reading has not met that standard.

Diagnosis: symptoms plus two morning samples

• Symptoms first. Look for reduced libido, fewer morning erections, erectile dysfunction, fatigue and low mood, and record them with a validated questionnaire so you can measure change.
• Two early-morning samples. The 2023 BSSM guideline says to measure total testosterone between 7am and 11am on at least two occasions, preferably 4 weeks apart, and not during acute illness. Fasting samples are preferred, because the 2017 guideline notes non-fasting levels can be up to 30% lower.
• Thresholds. The 2023 update treats total testosterone below 12 nmol/L, or calculated free testosterone below 225 pmol/L, as supporting treatment in a symptomatic man. Borderline results need judgement and a repeat, not an automatic prescription.
• SHBG and free testosterone. Measure SHBG and calculate free testosterone (the BSSM prefers the Vermeulen equation to analogue immunoassays) when total testosterone is borderline, and in men who are obese or older.
• LH and FSH. Measure them when testosterone is low, to separate primary (testicular) from secondary (pituitary or hypothalamic) deficiency.
• Prolactin. Check it when LH and FSH are low or testosterone is very low. The 2017 guideline recommends pituitary MRI if total testosterone is below 5.2 nmol/L with raised prolactin or low gonadotrophins. Refer these men to endocrinology rather than starting treatment yourself.

Look for secondary and reversible causes

The BSSM lists obesity, type 2 diabetes and metabolic syndrome, pituitary disease and hyperprolactinaemia, chronic kidney and liver disease, COPD and sleep apnoea, and medicines including opioids, glucocorticoids, antipsychotics and anticonvulsants. Ask directly about current or past anabolic steroid use, which suppresses the axis. Weight loss, treating sleep apnoea or changing a medicine may be the right first step.

Who should and shouldn’t be treated

The BSSM lists these contraindications to testosterone therapy:

Do not start TRT	Seek specialist advice first
Locally advanced or metastatic prostate cancer	An unevaluated prostate nodule or induration
Male breast cancer	PSA above 4 ng/mL (above 3 ng/mL in men at high risk)
An active wish to have children	Severe untreated sleep apnoea
Haematocrit above 0.54	Severe lower urinary tract symptoms
Severe heart failure (NYHA class IV)

Fertility needs its own conversation. Testosterone suppresses LH and FSH and therefore sperm production. The 2017 BSSM guideline says it frequently causes infertility after 6 to 12 months, and that this reverses in 60% to 70% of men within 9 to 12 months. Every SmPC says spermatogenesis may be suppressed. Ask every man about plans for children, now and in the future, and record the answer. Men who want to conceive need a specialist route, not standard TRT.

Consent, safeguarding and audit

• Consent. Use written information covering fertility, raised haematocrit, the prostate, gel transfer to partners and children (the Testogel SmPC warns about skin-to-skin transfer), and what happens if treatment stops.
• Safeguarding and misuse. Have a policy for men seeking supraphysiological doses for performance or bodybuilding, and for disclosed use of anabolic steroids from other sources. Decline, document and signpost.
• Audit. Audit the share of patients with two compliant morning samples before treatment, monitoring bloods done on time, haematocrit above 0.54 and the action taken, and symptom scores at 6 and 12 months.

Monitoring and stopping rules

What	When (BSSM)	Action
Symptoms and testosterone level	3, 6 and 12 months, then every 12 months	Aim for a mid-range level (the 2023 guideline suggests 15 to 30 nmol/L). Time the sample to the formulation.
Haematocrit	Baseline, 3 to 6 months, 12 months, then yearly	Above 0.54: reduce the dose or switch preparation. If it stays high, consider stopping and reintroducing at a lower dose.
PSA (and DRE at baseline)	Baseline, 3 to 6 months, 12 months, then yearly	The 2023 guideline advises urology evaluation if PSA rises by more than 1.4 ng/mL within a year.
Lipids and liver function	Monitor regularly during long-term treatment, as the SmPCs say	Review against cardiovascular risk.

Some SmPCs ask for more. Sustanon 250’s SmPC asks for DRE, PSA, haematocrit and haemoglobin quarterly for the first 12 months, then yearly. Follow the licence of the product you prescribe.

Write your stopping rules down. Stop or review if there is no meaningful symptomatic benefit after an adequate trial (the BSSM says at least 6 months, and maximal benefit often comes after 12), haematocrit stays above 0.54 despite dose changes, prostate or breast cancer is diagnosed, or the patient decides he wants children.

Prescribing testosterone: controlled drug rules, formulations and pharmacy partners

What Schedule 4 Part 2 means

Testosterone and its esters are listed in Schedule 4 Part 2 of the Misuse of Drugs Regulations 2001, alongside other anabolic steroids. In practice:

• The detailed prescription-writing requirements in regulation 15 do not apply to Schedule 4 drugs, so you can issue a normal private prescription, including an electronic one.
• A prescription for a Schedule 4 drug cannot be dispensed more than 28 days after its appropriate date (regulation 16).
• No controlled drugs register is required. Registers apply to Schedules 1 and 2 (regulation 19).
• Possession of Part 2 drugs is excepted from the offence of possession, which is one reason anabolic steroids are widely bought illegally. Supply without authority is still an offence.

Controlled drug status matters most for remote prescribing. The GMC says that if you don’t have access to relevant information from the patient’s medical records, you must not prescribe controlled drugs or medicines liable to misuse where monitoring is important, except in narrow urgent circumstances. It also expects robust identity checks, consent to contact the regular prescriber, and sharing all relevant information about the prescription with the patient’s GP. In practice, a man who refuses to let you contact his NHS GP is usually a man you should not start on TRT.

Formulations and licensing

• Gels (for example Testogel and Tostran) are applied daily. They are easy to stop if haematocrit rises, which is why many clinicians start with them. Counsel patients about transfer to partners and children.
• Long-acting testosterone undecanoate injection (Nebido) is given every 10 to 14 weeks after a loading dose. It needs an intramuscular injection by a trained clinician, so plan who gives it and where.
• Mixed testosterone esters (Sustanon 250) are a licensed shorter-acting injection.

The 2023 BSSM guideline notes that unlicensed short-acting injections are available through commercial sites but lack long-term safety data. If you plan to prescribe an unlicensed product, set out in your protocol why a licensed one won’t meet the patient’s needs, and check that your indemnity covers it.

In-house prescribing or a pharmacy partner

Most private GPs prescribe and use a partner pharmacy to dispense and deliver. Choose one that will dispense controlled drugs against private prescriptions and that understands your monitoring model. The GPhC’s guidance for distance-selling pharmacies (February 2025) says medicines liable to misuse, and medicines that need ongoing monitoring, should not be prescribed from a questionnaire alone. Expect the pharmacy to ask about your safeguards. Confirm each partner’s policy on Schedule 4 prescriptions directly.

Being tied to one pharmacy is a real risk. A good example of avoiding it is Jump, a newer record system on the market, which offers private e-prescribing with a choice of pharmacy partners: SignatureRx, Roseway, Chemist4U, Healistic and CloudRx. That means you and the patient keep a choice of pharmacy. Alternatives such as Semble, Hero Health or EMIS work differently, so compare which pharmacies each one connects to and whether they cover your service. See the private prescribing workflow and governance checklist for the wider process.

If you keep injectable stock to administer in clinic, treat it like any other stock medicine: order it in the clinic’s name, record what you receive and give, store it securely and check expiry dates.

Systems: records, results, recalls and NHS letters

• Clinical records with coded diagnoses, so you can run lists of everyone on TRT.
• Recalls for the 3, 6 and 12-month bloods and the annual review. Missed monitoring is the commonest way these services go wrong.
• Results handling with flags for haematocrit above 0.54 and PSA rises, and a named clinician responsible for acting on them.
• Pre-consultation questionnaires to collect symptom scores, medicines and fertility plans. Use them to prepare for the consultation, not to replace it.
• Letters to the NHS GP at the start of treatment and after each change. See sending consultation notes to a patient’s NHS GP.
• Laboratory partner that can process morning samples quickly and report haematocrit, PSA, SHBG and calculated free testosterone. See where to get pathology done.

Staff, training and indemnity

• Lead GP. Owns the protocol, prescribes, and holds the result-actioning responsibility. Training in men’s health and andrology is useful, and the BSSM and its guidelines are the obvious starting point.
• Nurse or healthcare assistant. Phlebotomy, blood pressure, height, weight and, for a nurse, intramuscular injections, with documented competence.
• Reception and admin. Booking morning blood slots, chasing missed monitoring, and recognising when to put a caller through to a clinician.
• Indemnity. Tell your indemnifier you are adding TRT, including any unlicensed products, remote prescribing or treatment of patients outside the UK, and get confirmation in writing.
• Peer review. Arrange case review with a colleague or an andrology or endocrinology contact, and agree referral routes for fertility, pituitary and urology problems.

Premises and equipment

A standard consulting room is enough, with an examination couch, chaperone arrangements for genital and rectal examination, phlebotomy equipment, a sharps bin, a calibrated blood pressure monitor and scales. If you give injections, you need anaphylaxis treatment and staff trained to use it. Morning clinic slots matter more than square footage, because diagnostic samples must be taken before 11am.

Pricing and unit economics

The figures below are illustrative only, to show the structure. They are not market data. Set your own prices from your costs and local competition.

Item (illustrative)	Price to patient	Main cost lines
Well man check (60 minutes, bloods included)	£295	GP time, nurse time, lab panel
Private testosterone test, two morning samples with GP review	£180	Two phlebotomy appointments, lab fees, GP review time
TRT assessment (consultation and examination)	£220	GP time, chaperone
Year-one monitoring (3 reviews and bloods)	£450	Lab fees, GP and nurse time
Ongoing membership after year one	£45 a month	Annual bloods, review time, recall admin

The medicine itself is usually paid by the patient to the dispensing pharmacy, so it is not your revenue. Your margin depends on:

• clinician time per patient, including results handling, which is easy to underprice
• lab fees for SHBG, LH, FSH, prolactin and PSA
• how many assessed men you don’t treat. A responsible clinic declines or defers a significant share, so price the assessment to stand on its own.
• missed-appointment rates for early-morning slots.

Other cost lines are indemnity, CQC (or devolved regulator) fees, your clinical system, card fees, consumables and marketing. For the wider model, see private GP pricing and break-even.

Marketing and advertising rules

• Don’t advertise testosterone. Under regulation 284 of the Human Medicines Regulations 2012, you may not publish an ad likely to lead to the use of a prescription-only medicine. CAP Code rule 12.12 says the same. The ASA treats almost any reference to a POM as promotion, including implied references through images, such as injection pens, or hashtags.
• Promote the consultation. CAP advice says a "consultation for the treatment of" a condition is likely to be acceptable if the medicine isn’t named or implied. "Men’s health assessment" or "testosterone deficiency consultation" is safer than "TRT from £X".
• Check landing pages. A compliant ad that links to a page promoting a POM can still breach the Code.
• Substantiate health statistics. The Numan ruling (August 2026) found prevalence claims about low testosterone misleading because the cited studies didn’t support them.
• Don’t run down GPs. The BioID Health ruling (August 2026) found ads claiming to "test deeper than your doctor" misleading and irresponsible.
• No before-and-after photos, endorsements by health professionals or celebrities, or performance and physique claims. Implying that testosterone improves muscle or performance in men without deficiency is also a clinical governance problem.

See advertising rules for private GPs.

Building out the men’s health clinic

• Erectile dysfunction. ED is often the presenting symptom. Treat it as a reason to assess cardiovascular risk, diabetes and testosterone, not just as a prescription. Sildenafil 50mg is also available from pharmacies as Viagra Connect for men over 18, so your value is the assessment.
• Cardiovascular risk. NICE NG238 recommends QRISK3 for people aged 25 to 84 without CVD, with priority for a full assessment at a 10-year risk of 10% or more. Many of your patients will also be eligible for a free NHS Health Check (age 40 to 74, every 5 years) in England.
• Prostate health discussions. In 2026 the UK National Screening Committee recommended against population screening. It recommended targeted screening every 2 years for men aged 45 to 61 with a pathogenic BRCA2 variant and a family history of breast, ovarian, pancreatic or prostate cancer. The NHS says routine PSA testing isn’t offered otherwise, but men can ask about it after a discussion of benefits and risks. The old Prostate Cancer Risk Management Programme page on GOV.UK now redirects to NHS information. Build that informed-choice discussion into your well man check rather than adding PSA to every panel by default (men on TRT are the exception, as monitoring is required).
• Mental health. Low mood is common in men presenting with fatigue or low libido, and it is not a testosterone problem. In England, men aged 18 and over can refer themselves to NHS Talking Therapies. For urgent help, signpost NHS 111 (mental health option), Samaritans on 116 123, or 999 in an emergency.

The NHS interface

Don’t build the service on the assumption that the NHS GP will take over prescribing or monitoring. The BMA’s position is that shared care with private providers is not recommended, that all shared care is voluntary and can be declined on clinical and capacity grounds, and that responsibility for prescribing and monitoring then stays with the private provider. NHS GPs should only arrange investigations needed for their own care of the patient, so don’t send your monitoring bloods to them.

What you should do:

• Get consent at registration to contact the NHS GP, and write when you start treatment, change the dose and stop. The GMC expects this, and the GP needs to know about a controlled drug.
• Ask for the relevant history (prostate, haematology, cardiovascular, medicines) before prescribing.
• If a patient later wants NHS treatment, the NHS will make its own assessment. Explain this up front so he isn’t surprised.

For tone and practicalities, see how independent GPs should communicate with NHS GPs.

Launch checklist

1. Confirm your registration covers the service: CQC treatment of disease, disorder or injury and diagnostic and screening procedures in England, or HIW, HIS or RQIA in the devolved nations. Apply for a variation if needed.
2. Write a TRT protocol based on the BSSM guidelines: diagnostic criteria, secondary-cause work-up, contraindications, fertility discussion, monitoring schedule and stopping rules.
3. Agree referral routes for endocrinology, urology and fertility.
4. Confirm indemnity in writing for TRT, injections, remote follow-up and any unlicensed products.
5. Choose a laboratory and book morning phlebotomy capacity.
6. Choose a pharmacy partner (or partners) and confirm their policy on Schedule 4 prescriptions.
7. Set up your clinical system: coding, recalls at 3, 6 and 12 months, result flags and NHS GP letter templates.
8. Write patient information and a consent form covering fertility, haematocrit, prostate, gel transfer and stopping.
9. Write a policy on supraphysiological dosing requests and anabolic steroid use.
10. Train staff on phlebotomy, injections, anaphylaxis, chaperoning and safeguarding, and record competence.
11. Check your website, ads and landing pages against CAP rule 12.12 and the ASA’s 2026 low-testosterone rulings.
12. Set prices that stand on their own when you decline to treat.
13. Schedule your first audit at 6 months.