Testosterone Injection Consent

WEIGHTLOSS | HORMONES | LONGEVITY

INFORMED CONSENT FOR INJECTABLE TESTOSTERONE REPLACEMENT THERAPY

Pharmaceutical & Compounded Hormone Therapy | Men’s Health & Andropause

1. Purpose and Authorization of Treatment

I voluntarily consent to injectable testosterone replacement therapy (TRT) prescribed and supervised by WildberryMD for the management of symptomatic testosterone deficiency, andropause, or age-related hormonal changes following individualized medical evaluation.

My prescribed therapy may include:

• FDA-approved pharmaceutical injectable testosterone
• Compounded injectable testosterone
• Compounded testosterone with DHEA
• Compounded testosterone with anastrozole

I understand that treatment is individualized according to symptoms, medical history, laboratory findings, and clinical response.

2. Potential Benefits

Testosterone therapy may improve:

• Sexual desire and certain aspects of sexual function.
• Energy, motivation, and sense of well-being.
• Muscle mass, strength, and body composition.
• Bone density and certain manifestations of testosterone deficiency.

I understand that benefits vary, treatment results are not guaranteed, and TRT is not a proven anti-aging or longevity treatment.

3. Potential Risks and Side Effects

Cardiovascular and Blood-Related Risks

• Increased red blood cell count and hematocrit (erythrocytosis).
• Increased blood pressure and fluid retention.
• Blood clots, including deep vein thrombosis and pulmonary embolism.
• Possible cardiovascular complications, particularly in patients with preexisting risk factors.

Prostate and Urinary Health

• Increased PSA or worsening urinary symptoms associated with prostate enlargement.
• Prostate-related risks requiring appropriate clinical assessment and monitoring.

Hormonal and Reproductive Effects

• Suppression of natural testosterone production.
• Reduced sperm production, testicular shrinkage, and possible infertility.
• Acne, oily skin, hair loss, breast tenderness, or enlargement.
• Mood changes, irritability, or worsening sleep apnea.

Injection-Related Risks

• Pain, bruising, bleeding, infection, allergic reactions, or other injection-site complications.

4. Cardiovascular Safety — TRAVERSE Study and FDA Updates

I understand that the TRAVERSE clinical trial, published in the New England Journal of Medicine in 2023, evaluated cardiovascular safety in 5,246 men aged 45–80 with testosterone deficiency and preexisting cardiovascular disease or increased cardiovascular risk.

The trial reported major cardiovascular events in:

• 7.0% of men receiving testosterone.
• 7.3% of men receiving placebo.

The study found that testosterone therapy was not associated with a greater incidence of major adverse cardiovascular events than placebo within the trial’s predefined safety margin.

However, atrial fibrillation, pulmonary embolism, and acute kidney injury occurred more frequently in the testosterone-treated group.

New England Journal of Medicine

Following the TRAVERSE findings, the FDA announced testosterone labeling changes in February 2025, including removal of cardiovascular boxed-warning language and additional warnings regarding increased blood pressure.

I understand that:

• TRAVERSE evaluated FDA-approved transdermal testosterone gel, not injectable or compounded testosterone.
• Its findings do not establish equivalent safety for compounded formulations containing DHEA and/or anastrozole.
• Testosterone therapy does not guarantee prevention of cardiovascular disease or increased longevity.
• Individual risk assessment and ongoing medical monitoring remain necessary.

5. Compounded Hormone Therapy Disclosure

If prescribed compounded injectable testosterone, with or without DHEA and/or anastrozole, I acknowledge that:

• Compounded medications are not FDA-approved and have not undergone FDA premarket review for safety, effectiveness, or quality.
• Individualized concentrations or combinations may differ from commercially available medications.
• Potential risks include dosing variability, contamination, medication errors, and unexpected adverse reactions.
• The safety and effectiveness of compounded hormone combinations have not been established through large clinical trials.
• FDA-approved testosterone alternatives may be available and have been discussed when appropriate.

I voluntarily consent to the prescribed compounded formulation based on my individualized medical needs.

6. Additional Hormonal Ingredients

DHEA (Dehydroepiandrosterone)

If my formulation contains DHEA, I understand that it is a hormone precursor that may be converted into testosterone and estrogen.

Potential adverse effects include acne, oily skin, mood changes, altered hormone levels, breast tenderness, and possible worsening of hormone-sensitive conditions.

I understand that the benefits and long-term safety of injectable DHEA combined with testosterone have not been adequately established.

Anastrozole

If my formulation contains anastrozole, I understand that it is an aromatase inhibitor used to reduce the conversion of testosterone into estradiol.

Its use in men for estrogen management during TRT is off-label.

Potential adverse effects include:

• Excessively low estradiol levels.
• Joint pain or muscle discomfort.
• Reduced bone mineral density and increased fracture risk.
• Changes in cholesterol levels.
• Fatigue, mood changes, or reduced sexual function.

I understand that estradiol is important for male bone health and sexual function, and excessive suppression may be harmful.

I acknowledge that DHEA and anastrozole are optional components and will be included only when specifically prescribed.

7. Fertility and Reproductive Health

I understand that testosterone therapy may suppress sperm production and impair fertility, potentially for a prolonged period or permanently.

I have informed my physician of any present or future desire to father children and understand that alternative treatments or fertility-preservation options may be appropriate.

8. Medical Monitoring and Patient Responsibilities

I agree to appropriate laboratory testing and follow-up, which may include:

• Total and free testosterone.
• Estradiol and DHEA-S, when indicated.
• Complete blood count, hemoglobin, and hematocrit.
• PSA and prostate evaluation, when appropriate.
• Blood pressure, metabolic markers, and other clinically indicated testing.

I understand that my physician may adjust, temporarily suspend, or discontinue therapy due to adverse effects, abnormal laboratory findings, or other medical concerns.

I agree to disclose my medical history, medications, supplements, and changes in health. I will use testosterone only as prescribed and will not share my medication or independently alter my dosage.

I understand that testosterone is a Schedule III controlled substance.

9. Alternatives to Treatment

I understand that alternatives may include lifestyle modification, weight management, resistance training, improved sleep, treatment of underlying medical conditions, and other appropriate hormonal or nonhormonal therapies.

I understand that I may decline or discontinue treatment after discussing the potential consequences with my physician.

10. Patient Acknowledgment and Voluntary Consent

By signing below, I acknowledge that:

• I have received an explanation of the proposed treatment, potential benefits, material risks, and reasonable alternatives.
• I understand the additional risks and uncertainties associated with compounded medications, DHEA, and anastrozole, when applicable.
• I understand the TRAVERSE cardiovascular safety findings and their limitations.
• I understand that treatment outcomes cannot be guaranteed.
• I have had the opportunity to ask questions and have received satisfactory answers.
• I agree to appropriate laboratory monitoring and follow-up.

I VOLUNTARILY AUTHORIZE WILDBERRYMD TO INITIATE AND MANAGE MY PRESCRIBED INJECTABLE TESTOSTERONE THERAPY, INCLUDING COMPOUNDED TESTOSTERONE WITH DHEA AND/OR ANASTROZOLE WHEN SPECIFICALLY PRESCRIBED AND DOCUMENTED.

11. Primary Care Physician (PCP) and Continuity of Medical Care

I understand that WildberryMD provides specialized hormone replacement therapy and wellness services and is not a substitute for my primary care physician (PCP).

I acknowledge and agree that:

• I am responsible for maintaining regular follow-up with my PCP for routine medical care, annual physical examinations, preventive screenings, vaccinations, and management of chronic medical conditions.
• I will continue appropriate care with my PCP and other specialists, including cardiology, urology, or endocrinology, when indicated.
• I understand that WildberryMD’s laboratory testing and medical evaluations are focused primarily on my hormone therapy and related health concerns and do not replace comprehensive primary care.
• I will inform my PCP of my testosterone therapy and disclose any significant changes in my health to WildberryMD.

I understand that my WildberryMD physician is not acting as my primary care physician and that I remain responsible for maintaining appropriate primary and preventive medical care.