What are the considerations and guidelines for using testosterone cream (topical testosterone) for low testosterone levels?

From the Guidelines

Testosterone cream should not be initiated for treatment of low testosterone levels in men without a clear diagnosis of hypogonadism, as the benefits and risks are not well established 1. When considering treatment for low testosterone levels, it is essential to evaluate the potential benefits, harms, costs, and patient preferences 1. The American College of Physicians suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter, and discontinue testosterone treatment if there is no improvement in sexual function 1.

Key Considerations

• The typical starting dose of topical testosterone cream ranges from 50-100 mg daily, applied to clean, dry skin of the shoulders, upper arms, or abdomen, avoiding genital areas unless specifically directed.
• Treatment should be monitored with blood tests at 2-3 months after starting therapy and periodically thereafter, aiming for testosterone levels in the mid-normal range (400-700 ng/dL).
• Side effects may include skin irritation, acne, increased body hair, and potential transfer to others through skin contact.
• To prevent transfer, wash hands thoroughly after application, allow the application site to dry completely before dressing, and cover the area with clothing.

Contraindications

• Testosterone therapy is contraindicated in men with prostate or breast cancer, untreated severe sleep apnea, severe heart failure, or elevated red blood cell counts.

Alternative Treatment Options

• The American College of Physicians suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar 1.

Patient Expectations

• Patients should expect gradual improvement in symptoms over 3-6 months, including increased energy, improved sexual function, and better mood, though individual responses vary. It is crucial to weigh the potential benefits and risks of testosterone cream treatment and consider alternative options before initiating therapy 1.

From the FDA Drug Label

Testosterone gel 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired). Hypogonadotropic hypogonadism (congenital or acquired).

Prior to initiating testosterone gel 1.62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range

Starting dose of testosterone gel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet), applied topically once daily in the morning.

Apply to clean, dry, intact skin of the shoulders and upper arms. Do not apply testosterone gel 1.62% to any other parts of the body including the abdomen, genitals, chest, armpits (axillae), or knees.

Dose adjustment: testosterone gel 1.62% can be dose adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets).

The considerations and guidelines for using testosterone cream (topical testosterone) for low testosterone levels are:

• Indications: Testosterone gel 1.62% is indicated for replacement therapy in males with primary or hypogonadotropic hypogonadism.
• Diagnosis: Confirm the diagnosis of hypogonadism by measuring serum testosterone on at least two separate days.
• Dosage: The starting dose is 40.5 mg of testosterone, applied topically once daily in the morning, with possible dose adjustments between 20.25 mg and 81 mg.
• Application: Apply to clean, dry, intact skin of the shoulders and upper arms, avoiding other parts of the body.
• Precautions: Avoid unintentional exposure of women or children to testosterone gel 1.62%, as secondary exposure can produce signs of virilization.
• Monitoring: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms, and evaluate patients with signs or symptoms consistent with deep vein thrombosis (DVT) or pulmonary embolism (PE) 2.

From the Research

Considerations for Using Testosterone Cream

• Testosterone cream, also known as topical testosterone, is a treatment option for low testosterone levels in men and women 3, 4.
• The potential benefits of testosterone cream include improved libido, increased bone mass, and increased sense of well-being 3, 4.
• However, there are also potential risks and side effects to consider, such as polycythemia, acne, and virilization in women 3, 4.

Guidelines for Using Testosterone Cream

• Testosterone therapy should only be initiated after two morning total serum testosterone measurements show decreased levels 4, 5.
• Patients should be counseled on the potential risks and benefits of testosterone therapy before starting treatment 4, 5.
• Monitoring of prostate-specific antigen, hematocrit, and lipid levels is recommended for patients taking testosterone 3, 5.
• Testosterone cream should be used under the guidance of a healthcare professional, and patients should be regularly monitored for adverse effects 5, 6.

Topical Testosterone Supplementation

• Topical testosterone supplementation, including creams and gels, is a modern formulation of testosterone replacement therapy 6.
• This type of therapy can yield more physiological concentrations of testosterone and is easier to use than other forms of testosterone replacement therapy 6.
• However, it is more expensive than other forms of therapy, and patient understanding and compliance with treatment and monitoring are crucial for clinical success 6.

Effectiveness and Safety of Testosterone Therapy

• The effectiveness and safety of testosterone therapy in obese men with low testosterone levels is still a topic of controversy 7.
• A systematic review of randomized controlled trials is needed to analyze the effectiveness of testosterone therapy for weight loss and preventing cardiovascular complications in this population 7.
• The review will examine outcomes such as weight loss, adverse events, quality of life, improvement of libido, control of obesity complications, frequency of cardiovascular events, and deaths 7.