Compounded Testosterone Cream 20% (Liposomal) — Informed Consent

INFORMED CONSENT FOR COMPOUNDED TESTOSTERONE CREAM (20% LIPOSOMAL)

§1 PURPOSE, CONTEXT, AND SCOPE

§1.1 This document constitutes an informed consent agreement between the Patient identified herein (the "Patient") and the Prescribing Physician acting on behalf of the Clinic. It is intended to document that the Patient has received, understood, and accepted comprehensive information regarding the proposed pharmacological use of a compounded testosterone cream (20% liposomal) for the treatment of hypogonadism (testosterone deficiency).

§1.3 Health optimization context: The Patient understands that the Clinic operates as a proactive health optimization / longevity practice. The Clinic is not an emergency provider. The Patient is responsible for maintaining an appropriate relationship with a primary care physician and/or relevant specialist(s) for diagnosis and management of disease, acute care, and emergencies.

§1.4 This consent is governed by the laws of Denmark and the European Union, including but not limited to the Danish Health Act (Sundhedsloven) and Regulation (EU) 2016/679 (General Data Protection Regulation).

§1.5 By signing this document, the Patient confirms they have had adequate time to read, consider, and ask questions, and that their questions have been answered to their satisfaction.

§3 MEDICATION, CLASS, AND DESCRIPTION OF TREATMENT

§3.1 Testosterone is a naturally occurring androgen hormone produced primarily by the testes in men. Testosterone replacement therapy (TRT) involves the administration of exogenous testosterone to restore physiological levels in individuals with documented hypogonadism.

§3.3 Compounded formulation: This prescription is for a compounded testosterone cream (20% liposomal). It is not an industrially manufactured, EMA‑authorised finished product. The medication is prepared by a compounding pharmacy to the Prescribing Physician's specification.

§3.4 Compounding notice (critical): The Patient understands that:

  • Compounded medicines are prepared by a pharmacy to a clinician's specification
  • Compared with industrially manufactured, EMA‑authorised products, compounded preparations may have:
  • Variability in concentration and potency
  • Variability in absorption and bioavailability
  • Batch‑to‑batch consistency differences
  • Different stability and shelf‑life characteristics
  • The Patient agrees to use only the designated compounding pharmacy
  • The Patient agrees to notify the Clinic immediately if they experience unexpected effects, lack of expected effect, or have concerns about the product quality

§3.5 Intended use in this Clinic: The Patient understands that this compounded testosterone cream is being prescribed for the treatment of hypogonadism (testosterone deficiency) based on clinical symptoms and/or biochemical evidence. The Patient understands that the use of a compounded formulation (as opposed to an EMA‑authorised product) is at the clinical discretion of the Prescribing Physician.

§3.6 Application instructions: The treatment will be applied topically to the skin at a site and dose determined by the Prescribing Physician. The Patient agrees to:

  • Follow the specific application instructions provided
  • Wash hands thoroughly after application
  • Allow the product to dry completely before covering with clothing
  • Avoid showering, swimming, or excessive sweating for a period after application (as instructed)

§4 REGULATORY STATUS AND APPROVED INDICATIONS

§4.1 Testosterone replacement therapy has been authorised by the European Medicines Agency (EMA) for the treatment of male hypogonadism when there is a deficiency or absence of endogenous testosterone.

§4.2 Compounded product status: The Patient understands that this specific compounded formulation (20% liposomal testosterone cream) is not an EMA‑authorised finished product. Compounded medications are prepared under pharmacy regulations but do not undergo the same regulatory review process as industrially manufactured medicines.

§4.3 On‑label indication (for testosterone generally): TRT is indicated for:

  • Primary hypogonadism (testicular failure)
  • Secondary hypogonadism (hypothalamic‑pituitary dysfunction)
  • Late‑onset hypogonadism (age‑related testosterone decline with clinical symptoms and biochemical confirmation)

§4.4 The Patient has been informed of the indication for which this compounded testosterone cream is being prescribed and accepts this information.

§5 PROPOSED BENEFITS OF TREATMENT

§5.1 The Patient understands that the potential benefits of TRT in the context of documented hypogonadism may include, but are not limited to:

§5.1.1 Symptom improvement: Improvement in symptoms associated with testosterone deficiency, such as:

  • Low libido and sexual dysfunction
  • Fatigue and reduced energy
  • Depressed mood or irritability
  • Reduced muscle mass and strength
  • Increased body fat
  • Reduced bone mineral density
  • Cognitive changes (e.g., reduced concentration)

§5.1.2 Metabolic effects: Potential improvements in insulin sensitivity, body composition, and lipid profiles in some individuals.

§5.1.3 Quality of life: Improvement in overall quality of life and sense of well‑being where symptoms were attributable to testosterone deficiency.

§5.2 No guarantee of benefit: The Patient acknowledges that the above benefits are potential and not guaranteed. Individual responses to TRT vary, and some patients may not experience the expected benefits or may experience them to a lesser degree. The Patient understands that TRT does not guarantee prevention of age‑related decline, extension of lifespan, or improvement in healthspan beyond addressing symptoms of hypogonadism.

§5.3 Compounding variability: The Patient understands that due to the compounded nature of this product, absorption, efficacy, and consistency may differ from industrially manufactured testosterone formulations, and individual responses may vary.

§6 MATERIAL RISKS AND ADVERSE EFFECTS

§6.1 The Patient has been informed of the following risks and adverse effects associated with TRT, including those specific to transdermal application and compounded formulations. The Patient understands that this list is not exhaustive and that other adverse effects may occur.

§6.2 Common adverse effects (occurring in ≥1% of patients):

  • Acne or oily skin
  • Increased body hair growth
  • Male pattern hair loss (androgenetic alopecia)
  • Mood changes (including irritability or aggression in some individuals)
  • Fluid retention and oedema
  • Sleep apnoea (worsening or new‑onset)
  • Skin irritation, redness, or rash at application site
  • Itching or burning sensation at application site

§6.3 Uncommon adverse effects (occurring in 0.1–1% of patients):

  • Erythrocytosis (elevated red blood cell count/haematocrit)
  • Elevated blood pressure
  • Changes in lipid profile
  • Gynecomastia (breast tissue enlargement)
  • Testicular atrophy (shrinkage of testes)
  • Suppression of spermatogenesis and infertility
  • Allergic contact dermatitis at application site

§6.4 Rare but serious adverse effects (occurring in <0.1% of patients or reported post‑marketing):

§6.4.1 Cardiovascular events: The Patient understands that the relationship between TRT and cardiovascular risk (including myocardial infarction, stroke, venous thromboembolism) is complex and remains an area of ongoing research. Some studies have suggested increased risk in certain populations, while others have not. The Patient understands that cardiovascular risk assessment and monitoring are important.

§6.4.2 Prostate health: The Patient understands that:

  • TRT may increase prostate size and prostate‑specific antigen (PSA) levels
  • TRT is contraindicated in patients with prostate cancer
  • The relationship between TRT and risk of developing prostate cancer is not fully established
  • Regular prostate monitoring (PSA, digital rectal examination) is recommended

§6.4.3 Polycythaemia (erythrocytosis): Elevated haematocrit/haemoglobin can increase the risk of thrombosis (blood clots). The Patient understands that regular monitoring of blood counts is required and that dose adjustment or phlebotomy may be necessary.

§6.4.4 Fertility suppression: TRT suppresses the hypothalamic‑pituitary‑gonadal axis, leading to reduced or absent sperm production. The Patient understands that TRT may cause irreversible infertility in some cases, particularly with long‑term use. The Patient understands that fertility preservation options (e.g., sperm banking) should be considered if future fertility is desired.

§6.4.5 Transfer risk (critical for transdermal formulations): Testosterone creams can be transferred to others through skin‑to‑skin contact, potentially causing serious adverse effects:

  • Children: May cause premature puberty, aggressive behaviour, or other serious effects
  • Women: May cause masculinisation, menstrual irregularities, or other effects

The Patient agrees to:

  • Apply the cream only to the prescribed site(s)
  • Wash hands thoroughly immediately after application
  • Cover the application site with clothing (e.g., shirt) to prevent direct contact
  • Avoid skin‑to‑skin contact with others (especially children and partners) until the site has been thoroughly washed
  • Shower or wash the application site before any intimate contact
  • Store the medication securely out of reach of children

§6.4.6 Compounding‑specific risks: The Patient understands that:

  • Compounded products may have variable absorption, leading to unpredictable serum testosterone levels
  • Batch‑to‑batch variability may affect efficacy or adverse effects
  • The Patient must report any unexpected effects, lack of expected effect, or concerns about product quality immediately

§6.4.7 Allergic reactions: Rare allergic reactions can occur. The Patient must seek urgent care for swelling of face/tongue/throat, difficulty breathing, or widespread rash.

§7 CONTRAINDICATIONS AND PRECAUTIONS

§7.1 The Patient confirms that they have disclosed all relevant medical history to the Prescribing Physician. TRT is generally contraindicated or requires special caution in the following circumstances:

§7.2 Absolute contraindications:

  • Known hypersensitivity or allergy to testosterone or any excipients in the compounded formulation
  • Prostate cancer (known or suspected)
  • Breast cancer (in men)
  • Severe cardiac, hepatic, or renal impairment (relative contraindication; requires careful assessment)

§7.3 Relative contraindications and precautions:

  • Benign prostatic hyperplasia (BPH) with significant lower urinary tract symptoms
  • Elevated haematocrit (>50% or as determined by clinician)
  • Untreated severe sleep apnoea
  • History of cardiovascular disease or high cardiovascular risk
  • History of venous thromboembolism
  • Uncontrolled heart failure
  • Severe liver disease
  • Desire for fertility (TRT suppresses spermatogenesis)
  • Household members who are children or others who may come into skin contact with the Patient
  • Use in women (except under specialist supervision for specific indications)
  • Use in children or adolescents (except under specialist supervision)

§8 DRUG INTERACTIONS

§8.1 The Patient has disclosed all current medications, including prescription drugs, over‑the‑counter medications, supplements, and herbal products. The following interactions are of clinical significance:

§8.2 Anticoagulants: Testosterone may affect coagulation parameters; monitoring may be required.

§8.3 Corticosteroids: Concomitant use may increase the risk of fluid retention and oedema.

§8.4 Insulin and diabetes medications: TRT may affect insulin sensitivity; glucose monitoring may be required.

§8.5 The Patient agrees to inform the Clinic before starting any new medication.

§9 MONITORING REQUIREMENTS

§9.1 The Patient agrees to undergo monitoring as recommended by the Prescribing Physician, which may include:

§9.2 Baseline assessments (before starting TRT):

  • Total and free testosterone levels
  • Luteinising hormone (LH) and follicle‑stimulating hormone (FSH)
  • Complete blood count (CBC), including haematocrit/haemoglobin
  • Prostate‑specific antigen (PSA)
  • Lipid profile
  • Liver function tests
  • Blood pressure
  • Digital rectal examination (DRE) of the prostate (if indicated)
  • Assessment of sleep apnoea risk

§9.3 Ongoing monitoring (typically every 3–6 months initially, then as clinically indicated):

  • Testosterone levels (to assess adequacy and avoid supraphysiological levels)
  • Haematocrit/haemoglobin (to monitor for erythrocytosis)
  • PSA (to monitor prostate health)
  • Lipid profile
  • Liver function tests
  • Blood pressure
  • Clinical assessment of symptoms and adverse effects
  • Assessment of application site for skin reactions

§9.4 Dose adjustment: The Patient understands that TRT dosing may be adjusted based on clinical response, laboratory values, and adverse effects. The Patient agrees to follow dosing instructions and not to self‑adjust the dose.

§9.5 Discontinuation considerations: The Patient understands that abrupt discontinuation of TRT may lead to return of hypogonadal symptoms. The Patient agrees to consult with the Prescribing Physician before discontinuing treatment.

§10 ALTERNATIVE TREATMENTS

§10.1 The Patient has been informed of the following alternatives to compounded testosterone cream:

§10.2 EMA‑authorised testosterone formulations: Industrially manufactured testosterone products (e.g., gels, patches, injections) that have undergone EMA regulatory review.

§10.3 Lifestyle modification: Weight loss, exercise, adequate sleep, stress management, and addressing contributing factors (e.g., medications that may suppress testosterone) may improve symptoms in some cases.

§10.4 Treatment of underlying causes: If hypogonadism is secondary to another condition (e.g., obesity, sleep apnoea, medications), addressing the underlying cause may restore testosterone production.

§10.5 No treatment: The Patient may choose not to receive TRT, understanding that untreated hypogonadism may lead to persistent symptoms and, in some cases, increased risk of osteoporosis, fractures, and other complications.

§10.6 The Patient confirms that these alternatives have been discussed and that they have chosen to proceed with compounded testosterone cream.

§12 LIMITATION OF LIABILITY / NO GUARANTEE

§12.1 The Patient understands that medicine is not an exact science and no outcomes can be guaranteed.

§12.2 The Patient understands that adverse effects may occur despite appropriate prescribing and monitoring.

§12.3 The Patient understands that compounded products may have variability in quality, consistency, and efficacy compared with industrially manufactured products, and accepts this risk.

§12.4 Nothing in this consent excludes liability that cannot be excluded under applicable Danish law.

§13 WITHDRAWAL OF CONSENT

§13.1 The Patient may withdraw consent at any time by contacting the Clinic. The Prescribing Physician will provide guidance on safe discontinuation where applicable.

§14 DATA PROTECTION AND RECORDKEEPING

§14.1 The Patient's personal data and health information will be processed in accordance with GDPR and applicable Danish law.

§14.2 This consent may be retained as part of the Patient's medical record.

§15 ACKNOWLEDGMENTS AND DECLARATIONS

By consenting, the Patient confirms the following:

  • I have read this consent document in its entirety, or it has been read to me, and I understand its contents.
  • I understand this is a compounded testosterone cream (20% liposomal) and may differ from industrially manufactured, EMA‑authorised products.
  • I understand the medication prescribed (the prescribed medication) and the purpose of TRT for hypogonadism.
  • I understand that benefits are variable and not guaranteed.
  • I understand the material risks, including cardiovascular events, prostate health considerations, erythrocytosis, fertility suppression, and transfer risk to others (especially children and partners).
  • I understand and agree to follow all application instructions and transfer prevention measures.
  • I understand that regular monitoring (including PSA, haematocrit, lipids) is required.
  • I understand the contraindications and have disclosed all relevant medical history.
  • I have disclosed all relevant medical history and current medications to the Clinic.
  • I understand I must seek urgent/emergency care for severe symptoms and that the Clinic is not an emergency service.
  • I have had the opportunity to ask questions and my questions were answered.
  • I voluntarily consent to commence or continue treatment with the prescribed medication under the regimen agreed with my clinician.