What is the recommended management plan for a patient already on testosterone gel (testosterone) therapy?

Management of Patients Already on Testosterone Gel

For patients already on testosterone gel, the priority is systematic monitoring of testosterone levels, clinical response, and safety parameters—with dose adjustments targeting mid-normal testosterone levels (450-600 ng/dL) and discontinuation if no symptomatic benefit is achieved despite adequate levels. 1

Immediate Monitoring Requirements

Testosterone Level Assessment

• Measure total testosterone levels 2-3 months after any dose change, then every 6-12 months once stable. 1
• For testosterone gel, levels can be measured at any time after 2-3 months of stable therapy (unlike injections which require midpoint timing). 2
• Target mid-normal range of 450-600 ng/dL—use minimal dosing necessary to achieve this range. 1

Safety Monitoring Panel

• Check hematocrit at each visit—withhold treatment immediately if >54% and consider phlebotomy in high-risk cases. 1, 2
• Monitor PSA levels in men over 40 years—refer for urologic evaluation if PSA increases >1.0 ng/dL in first 6 months or >0.4 ng/dL per year thereafter. 1, 2
• Perform digital rectal examination to assess for prostate abnormalities. 2
• Assess for symptoms of benign prostatic hyperplasia. 2

Dose Adjustment Algorithm

If Testosterone Levels Are Low (<450 ng/dL)

• Increase dose by one pump actuation (20.25 mg) if current dose is below maximum. 3
• Maximum dose is 81 mg daily (4 pump actuations). 3
• Recheck testosterone levels 2-3 weeks after dose adjustment. 3

If Testosterone Levels Are High (>750 ng/dL)

• Decrease dose by one pump actuation (20.25 mg). 3
• Recheck levels 2-3 weeks after adjustment. 3

If Testosterone Levels Are Mid-Normal (450-600 ng/dL)

• Continue current dose without adjustment. 1
• Assess clinical response—if no improvement in sexual function after 3-6 months at target levels, discuss discontinuation. 1

Clinical Response Assessment

Expected Benefits (Set Realistic Expectations)

• Small but significant improvements in sexual function and libido (standardized mean difference 0.35)—this is the primary indication. 2
• Modest improvements in quality of life, primarily in sexual function domains. 2
• Little to no effect on physical functioning, energy, vitality, depressive symptoms, or cognition. 2

Discontinuation Criteria

• If patient achieves target testosterone levels (450-600 ng/dL) but reports no improvement in sexual function after 3-6 months, discontinue therapy. 1
• There is no utility in continuing testosterone therapy without symptomatic benefit. 1

Critical Safety Considerations

Absolute Contraindications (Stop Immediately If Present)

• Active desire for fertility preservation—testosterone causes azoospermia and must be stopped, with gonadotropin therapy (hCG plus FSH) offered instead. 1, 2
• Active or treated male breast cancer. 2
• Hematocrit >54%. 1, 2
• Recent cardiovascular event within past 3-6 months. 1

Skin-to-Skin Transfer Prevention

• Application site must be covered with clothing (e.g., short-sleeve t-shirt) after gel dries. 3
• Wash hands thoroughly with soap and water immediately after application. 3
• Children and women must avoid contact with unwashed or unclothed application sites—risk of virilization in women and precocious puberty in children. 1, 3
• Wash application site thoroughly with soap and water before anticipated skin-to-skin contact. 3

Application Site Verification

Correct Application Technique

• Apply only to shoulders and upper arms—do NOT apply to abdomen, genitals, chest, armpits, or knees. 3
• Limit application area to what will be covered by a short-sleeve t-shirt. 3
• Apply to clean, dry, intact skin. 3
• Avoid swimming, showering, or washing application site for minimum 2 hours after application. 3

Common Application Errors to Avoid

• Applying to incorrect body sites (abdomen, chest)—this reduces absorption and efficacy. 3
• Not covering application site with clothing—increases transfer risk. 3
• Showering within 2 hours of application—reduces testosterone absorption. 3

Formulation-Specific Considerations

When to Consider Switching from Gel to Injections

• Maximum gel dose (81 mg daily) fails to achieve adequate testosterone levels. 4
• Cost is prohibitive (annual cost ~$2,135 for gel vs. ~$156 for injections). 2, 4
• Patient preference after experiencing gel for adequate trial period. 4

When to Maintain Gel Therapy

• Cardiovascular risk factors present (elderly, diabetes, hypertension, known CAD)—gel has superior cardiovascular safety profile. 4, 5
• Hematocrit 50-54% (gel has 3-fold lower erythrocytosis risk: 15.4% vs. 43.8% with injections). 5
• Patient preference for stable day-to-day testosterone levels without mood/energy fluctuations. 4, 5

Management of Elevated Hematocrit on Gel

Hematocrit 50-52%

• Continue current therapy with closer monitoring (every 3 months). 2
• Consider dose reduction by one pump actuation if trending upward. 2

Hematocrit 52-54%

• Reduce testosterone dose by 25-50% (1-2 pump actuations). 2
• Recheck hematocrit in 4-6 weeks. 2

Hematocrit >54%

• Withhold testosterone therapy immediately. 1, 2
• Consider therapeutic phlebotomy in high-risk patients (elderly, cardiovascular disease). 2
• Do not restart until hematocrit <52%. 2

Special Clinical Scenarios

Obesity-Associated Secondary Hypogonadism

• Attempt weight loss through low-calorie diet and regular exercise before continuing testosterone—this can improve testosterone levels without medication. 2
• Weight loss of 5-10% can significantly increase endogenous testosterone production. 2

Congestive Heart Failure

• Use caution due to fluid retention risk—target mid-range testosterone levels (350-600 ng/dL) rather than upper-normal. 2
• Monitor for signs of fluid retention at each visit. 2

Borderline Testosterone Levels (231-346 ng/dL)

• Consider 4-6 month trial with careful discussion of risks/benefits—continue beyond 6 months only if clinical benefit demonstrated. 2
• Measure free testosterone by equilibrium dialysis if total testosterone borderline. 2

Common Pitfalls to Avoid

• Do not continue therapy indefinitely without monitoring—nearly half of men on testosterone never have levels checked, which is dangerous practice. 2
• Do not assume all symptoms will improve—testosterone has minimal to no benefit for energy, physical function, mood, or cognition even with confirmed hypogonadism. 2
• Do not ignore mild erythrocytosis (hematocrit 50-52%) in elderly or cardiovascular patients—even modest elevations increase thrombotic risk. 2
• Do not start or continue testosterone in men seeking fertility—this causes prolonged and potentially irreversible azoospermia. 1, 2
• Do not apply gel to abdomen or chest—this is off-label and reduces efficacy. 3