Consent for Men’s Hormone Optimization

Purpose of Treatment

Hormone optimization therapy for men is used to evaluate and treat symptoms related to low or suboptimal testosterone levels and related hormone imbalances. Symptoms may include:

  • Low energy or fatigue

  • Reduced libido or erectile changes

  • Decreased muscle mass or strength

  • Increased body fat

  • Poor recovery from exercise

  • Low motivation, mood changes, or brain fog

  • Reduced bone density

The goal of treatment is symptom improvement and restoration of hormone levels into a healthy physiologic range, not performance enhancement or supraphysiologic dosing.

Cost of Treatment Program

The men’s hormone optimization program is a monthly recurring membership fee of $49/month. This fee covers:

  • Medical provider oversight

  • Treatment planning

  • Ongoing monitoring

  • Lab interpretation

  • Medication management

Laboratory testing and medications are not included and are billed separately.

Laboratory Costs

  • Labs are required prior to starting treatment

  • Labs may be completed using insurance (if covered) or self-pay options 

  • Self-Pay Lab Fees:

    • Initial Comprehensive Labs

  • Males: $200

  • Females: $170

  • Repeat Labs

    • Males: $110

    • Females: $85

  • Follow-up labs are required:

    • 8–10 weeks after starting or changing therapy

    • Then every 3–6 months for safety and monitoring

Hormone Therapy Options and Cost Reviewed

Treatment options are individualized based on symptoms, lab results, fertility goals, medical history, cost, and patient preference.

Option 1: Enclomiphene (Fertility-Preserving Therapy)

  • What it is: An oral medication that stimulates the body to produce its own testosterone while preserving sperm production and testicular size.

  • Dosing: Take one capsule orally daily.

  • Cost: Dispensed through a compounding pharmacy, $60–$70/month.

  • Why it may be chosen: Men wishing to maintain fertility, younger patients, or those with secondary (brain-signaling) low testosterone.

  • Potential benefits: Increased natural testosterone production, preserved fertility and testicular size, oral dosing without injections. It usually moderately raises testosterone, but not as high as direct testosterone.

  • Risks and side effects: Headaches, mood changes, rare visual disturbances, and possible reduced effectiveness in primary testicular failure. Titrating the dose slowly may avoid side effects.

  • Can also be used in combination with injectable testosterone to help preserve testicular size instead of taking gonadorelin or hCG


Option 2: new Oral Testosterone (Kyzatrex)

  • What it is: New to market FDA-approved oral testosterone absorbed through the lymphatic system rather than traditional liver metabolism.

  • Dosing: Twice a day with fat-containing food

  • Cost: Dispensed through a compounding pharmacy and is not covered by insurance
    $250 for a 2-month supply (400 mg daily) - starting dose and most stay here.
    $450 for a 2-month supply (800 mg daily)

  • Why it may be chosen: Preference for oral therapy and avoidance of injections or skin transfer risks with topical.

  • Potential benefits: Raises testosterone levels consistently, avoiding the peaks and troughs associated with twice-weekly injections.

  • Risks and side effects: Suppression of sperm production, increased red blood cell count, strict dosing requirements with meals, and lack of insurance coverage. Not showing same sperm production as injections in trials, though there is still a risk.

Option 3: Injectable Testosterone (Subcutaneous Route)

  • What it is: Testosterone injected under the skin using small needles. It has the same effectiveness as old-school intramuscular injections.

  • Dosing: Typically injected twice weekly. Does not require refrigeration.

  • Cost: $200 for 20 weeks of medication. Dispensed through a compounding pharmacy and is not covered by insurance. 

  • Why it may be chosen: Most reliable and consistent absorption, lower cost compared to oral options, and improved symptom control for many patients.

  • Potential benefits: Stable testosterone levels, less daily management, and good tolerability when dosed appropriately.

  • Risks and side effects: Suppression of sperm production, increased red blood cell count, acne or oily skin, and the need for self-injection. If used alone, testicular atrophy/shrinkage may occur. If this is a major concern, we coudl add gondarelin or hcg injections or oral enclomiphene to keep endogenous testosterone production.

Option 4: Topical Testosterone Gel

  • What it is: Daily applied testosterone gel absorbed through the skin.

  • Why it may be chosen: Preference for non-injectable therapy and potential insurance coverage if criteria are met.

  • Cost: may be covered by insurance only if strict lab criteria for hypogonadism are met; otherwise, retail cost is approximately $50/month.

  • Potential benefits: Easy daily application and no injections.

  • Risks and side effects: Risk of transferring testosterone to partners or children, skin irritation, variable absorption, and suppression of sperm production.

  • Most patients do not choose this as it requires a daily topical application.


Patients are encouraged to request medication cost estimates prior to starting therapy.

Updated Safety & Regulatory Information

  • The FDA has removed the prior black box cardiovascular warning associated with testosterone therapy.

  • Current evidence supports that testosterone therapy, when appropriately prescribed and monitored, does not increase cardiovascular risk in healthy men.

  • Risk assessment remains individualized based on dose, formulation, route, and patient health.

  • This update does not eliminate all risks, and ongoing monitoring is required.

Monitoring and Follow-Up Requirements

Patients agree to:

  • Complete baseline labs prior to therapy

  • Repeat labs 8–10 weeks after initiation or dose changes

  • Continue monitoring every 3–6 months

  • Report side effects promptly

  • Attend required follow-up visits

Therapy may be adjusted, paused, or discontinued for safety reasons.

Potential Side Effects of Testosterone Replacement Therapy (TRT)

Testosterone therapy is generally well tolerated when appropriately prescribed and monitored, but side effects can occur. Not all patients experience these effects.


Common or Mild Side Effects

  • Acne or oily skin

  • Increased sweating

  • Fluid retention or mild swelling

  • Increased facial or body hair

  • Mood changes, such as irritability or anxiety

  • Changes in libido (increase or, less commonly, decrease)

  • Injection site irritation (for injectable therapy)

  • Skin irritation or rash (for topical gels)

Blood & Cardiovascular-Related Effects

  • Increased red blood cell count (hematocrit), which can thicken the blood and increase clot risk if not monitored

  • Changes in cholesterol levels, including possible lowering of HDL (“good cholesterol”)

  • Fluid retention, which may worsen blood pressure or heart conditions in susceptible individuals

Current evidence shows no increased cardiovascular risk in healthy men when TRT is appropriately dosed and monitored, but individual risk factors must be considered.

Fertility & Testicular Effects

  • Reduced sperm production

  • Decreased fertility, which may be reversible after stopping therapy but is not guaranteed

  • Testicular shrinkage, due to reduced natural testosterone production


Prostate-Related Effects

  • Increase in PSA (prostate-specific antigen) levels

  • Worsening of urinary symptoms in men with benign prostate enlargement

  • Testosterone therapy does not cause prostate cancer, but may accelerate growth of existing prostate cancer

Sleep & Respiratory Effects

  • Worsening of untreated sleep apnea

  • Increased snoring in some individuals

Hormonal & Estrogen-Related Effects

  • Breast tenderness or enlargement (gynecomastia) due to conversion of testosterone to estrogen

  • Water retention or bloating

Rare or Serious Side Effects

  • Blood clots (rare when monitored appropriately)

  • Liver strain (primarily associated with certain oral formulations)

  • Allergic reactions to medication components (rare)

When to Contact Your Provider Immediately

  • Shortness of breath or chest pain

  • Severe swelling in legs

  • Sudden vision changes

  • Severe headaches

  • Signs of infection at injection sites


Individuals Who Should Use Caution

Careful evaluation is required for men with:

  • History of prostate cancer

  • Elevated PSA without evaluation

  • Untreated sleep apnea

  • Elevated hematocrit

  • Significant cardiovascular disease

  • Liver disease

Contraindications

Testosterone therapy is generally contraindicated in individuals with:

  • Active prostate or breast cancer

  • Uncontrolled polycythemia

  • Severe untreated sleep apnea

  • Hypersensitivity to medication components

  • Use of supraphysiologic or non-prescribed dosing

Acknowledgment and Consent

I acknowledge that I have discussed the benefits, risks, alternatives, and limitations of men’s hormone optimization therapy. I understand that no hormone therapy is risk-free, fertility may be affected depending on treatment choice, and ongoing lab monitoring is required. I understand the program costs, insurance limitations, and that I may discontinue treatment at any time by notifying the clinic in writing. I consent to treatment as outlined above.