What is the risk of topical testosterone (testosterone) gel transfer to a spouse in a male patient with hypogonadism?

From the Guidelines

Topical testosterone gel used for male hypogonadism carries a significant risk of transfer to a spouse or partner through skin-to-skin contact. To minimize this risk, patients should apply the gel (such as AndroGel, Testim, or Fortesta) to clean, dry skin of the shoulders, upper arms, or abdomen as directed, and allow it to dry completely for 5-10 minutes before covering the area with clothing. The application site should be washed thoroughly with soap and water before any skin contact with a partner. Ideally, patients should shower before intimate contact or cover the application site with clothing. Female partners exposed to testosterone may develop unwanted masculinizing effects including acne, hair growth, voice deepening, and menstrual irregularities. Children are particularly sensitive to testosterone exposure, so extra precautions should be taken around them. If transfer is a significant concern, alternative testosterone formulations like injections or implantable pellets might be considered. These precautions are necessary because testosterone gel remains on the skin surface for 24 hours after application and can easily transfer through direct contact 1.

Key Considerations

• The risk of transfer is a significant concern, particularly for female partners and children, who may experience unwanted masculinizing effects 1.
• Patients should follow proper application and hygiene procedures to minimize the risk of transfer.
• Alternative testosterone formulations may be considered if transfer is a significant concern.
• The benefits and harms of testosterone treatment should be carefully weighed, particularly in older men with low testosterone levels without well-established medical conditions known to cause hypogonadism 1.

Recommendations

• Patients using topical testosterone gel should be aware of the risk of transfer and take steps to minimize it.
• Healthcare providers should counsel patients on proper application and hygiene procedures.
• Alternative testosterone formulations should be considered for patients who are concerned about the risk of transfer.
• Further research is needed to fully understand the benefits and harms of testosterone treatment in men without established conditions that cause permanent testicular or hypothalamic–pituitary dysfunction 1.

From the FDA Drug Label

Patients should wash their hands with soap and water immediately after applying testosterone gel 1.62%. Patients should cover the application site(s) with clothing (e.g., a t-shirt) after the gel has dried. Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue. In the event that unwashed or unclothed skin to which testosterone gel 1. 62% has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible. Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Children and women should avoid contact with unwashed or unclothed application sites in men using testosterone gel 1.62%

The risk of gel transfer to a spouse is present with topical testosterone gel. To minimize this risk, patients should wash their hands after applying the gel, cover the application site with clothing, and wash the application site before direct skin-to-skin contact. If transfer occurs, the area of contact on the spouse should be washed with soap and water as soon as possible. Women, in particular, should avoid contact with unwashed or unclothed application sites in men using testosterone gel 1.62% due to the risk of virilization 2.

From the Research

Male Hypogonadism and Topical Testosterone Gel

• Male hypogonadism is characterized by inadequate production of testosterone and deficiencies in spermatogenesis, with testosterone replacement therapy (TRT) being the main treatment 3.
• Transdermal application of testosterone gels is a commonly used route of testosterone administration, but it carries a risk of transfer of testosterone to partners and family 4.

Risk of Gel Transfer to Spouse

• The risk of gel transfer to spouses or family members is a concern with topical testosterone gel therapy, as it can lead to unintended exposure to testosterone 4.
• However, there is limited information available on the specific risk of gel transfer to spouses and the measures that can be taken to minimize this risk.

Available Treatment Options

• Various treatment options are available for male hypogonadism, including topical testosterone gels, injectable testosterone formulations, and oral testosterone formulations 3, 5, 6.
• The selection of the treatment method depends on the patient's preference, with advice from the physician, and the patient's individual needs and health status 6, 7.

Considerations for Treatment

• Testosterone therapy can induce reversible suppression of spermatogenesis, and alternative treatments such as human chronic gonadotropin, selective estrogen receptor modulator, estrogen antagonist, or an aromatase inhibitor may be used if fertility is desired 6.
• The use of hepatotoxic androgens should be avoided, and the patient's health status and medical history should be taken into account when selecting a treatment method 3, 6.