What is the starting dose of topical testosterone for an adult male with hypogonadism?

Starting Dose of Topical Testosterone

The recommended starting dose of topical testosterone gel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied once daily in the morning to the shoulders and upper arms. 1

FDA-Approved Dosing Guidelines

The FDA label for testosterone gel 1.62% provides clear dosing parameters 1:

• Starting dose: 40.5 mg of testosterone applied topically once daily in the morning 1
• Minimum dose: 20.25 mg (1 pump actuation or single 20.25 mg packet) 1
• Maximum dose: 81 mg (4 pump actuations or two 40.5 mg packets) 1
• Application site: Shoulders and upper arms only—do not apply to abdomen, genitals, chest, armpits, or knees 1

Dose Titration Protocol

Titrate the dose based on pre-dose morning serum testosterone measured at approximately 14 days and 28 days after starting treatment. 1 The European Association of Urology recommends the same 40.5 mg daily starting dose for transdermal testosterone gel as first-line formulation 2.

Titration Criteria 1:

• If pre-dose testosterone >750 ng/dL: Decrease daily dose by 20.25 mg 1
• If pre-dose testosterone 350-750 ng/dL: Continue current dose 1
• If pre-dose testosterone <350 ng/dL: Increase daily dose by 20.25 mg 1

Target mid-normal testosterone levels of 500-600 ng/dL when monitoring patients on testosterone therapy 2.

Application Instructions

The application technique matters for optimal absorption 1:

• Apply to clean, dry, intact skin of upper arms and shoulders 1
• Limit application area to what would be covered by a short-sleeve t-shirt 1
• Use palm of hand to spread gel across maximum surface area 1
• Once dry, cover application site with clothing 1
• Avoid swimming, showering, or washing the site for minimum 2 hours after application 1
• Wash hands thoroughly with soap and water after application 1

Application site matters: Arms/shoulders achieve higher testosterone levels than chest/abdomen or legs, with arms/shoulders being the FDA-approved and most effective site 3.

Monitoring Requirements

Before initiating therapy, confirm hypogonadism diagnosis with morning testosterone measured on at least two separate days, with levels below the normal range 1.

Ongoing Monitoring 2, 4:

• Initial monitoring: Check testosterone levels at 2-3 months after treatment initiation or any dose change 2, 4
• Long-term monitoring: Once stable, monitor every 6-12 months 2, 4
• Hematocrit monitoring: Check periodically and withhold treatment if >54% 2, 4
• PSA monitoring: Check in men over 40 years before starting and periodically during treatment 2, 4

Alternative Formulations

While 1.62% gel at 40.5 mg daily is the standard starting dose, other formulations exist 5, 6:

• Testosterone gel 2%: Starting dose 23 mg/day (single pump actuation), with uptitration to 46 mg/day after 2 weeks if 4-hour testosterone level <500 ng/dL 6
• Testosterone gel 1%: Different dosing than 1.62% formulation—refer to specific product labeling 1

Critical caveat: Topical testosterone products have different doses, strengths, and application instructions that result in different systemic exposure—they are not interchangeable 1.

Absolute Contraindications

Do not initiate testosterone gel in men with 2, 4, 1:

• Active male breast cancer 2, 4
• Men actively seeking fertility (testosterone suppresses spermatogenesis and causes azoospermia) 2, 4
• Hematocrit >54% 2, 4
• Prostate-specific antigen >2.5 ng/mL without urologic evaluation 1

Expected Outcomes

Set realistic expectations with patients 2:

• Sexual function improvement: Small but significant improvements (standardized mean difference 0.35) 2
• Minimal benefit for: Physical functioning, energy, vitality, depressive symptoms, or cognition 2
• Body composition: Increased lean mass and decreased fat mass correlate with achieved testosterone levels 7
• Symptom improvement: Maximal improvement in sexual function and mood typically occurs by day 30 of treatment 7

If no improvement in sexual function after 12 months, discontinue treatment to prevent unnecessary long-term exposure to potential risks without benefit 2.