Testosterone Therapy in Elderly Females

Introduction to Testosterone Therapy

• Testosterone therapy may increase adverse cardiovascular events, particularly in older adults with higher baseline risk, although evidence is of low certainty and most studies excluded individuals with recent cardiovascular disease, limiting generalizability to elderly populations 1

Safety Considerations

• Elderly females are at higher baseline risk for cardiovascular events, and most studies on testosterone treatment excluded individuals with recent cardiovascular disease, limiting generalizability to this population 1
• Erythrocytosis is a significant dose-dependent risk, occurring in 3-18% with transdermal administration and up to 44% with injection therapy, potentially aggravating vascular disease 2
• Fluid retention can be problematic for patients with congestive heart failure or renal insufficiency 2
• Possible worsening of sleep apnea, particularly with higher testosterone levels 3

Benefits of Testosterone Therapy

• No established benefits of testosterone therapy for women of advanced age (75+) have been found, with most studies focused on sexual function improvements in younger postmenopausal women 1

Guideline Recommendations

• The American College of Cardiology and other guideline societies have not provided specific recommendations for testosterone therapy in elderly females, but available evidence suggests that risks likely outweigh potential benefits in this age group 1
• The American Diabetes Association recommends confirming the diagnosis with morning total testosterone measurement and assessing for symptoms of hypogonadism in patients with testosterone levels below 300 ng/dL 4
• The American College of Physicians recommends initiating testosterone replacement therapy with intramuscular formulation, targeting mid-normal testosterone range, and monitoring for adverse effects 1
• Discuss with patient the expected benefits of TRT, including improved sexual function and modest improvements in quality of life, as well as potential risks 1
• Monitor for sleep apnea, which can worsen with testosterone therapy, as recommended by the American Diabetes Association 4
• Testosterone therapy should be discontinued if there is no improvement in symptoms after 12 months, as recommended by the American College of Physicians 1
• Baseline assessment should include PSA, digital rectal examination, hematocrit or hemoglobin level, lipid evaluation (optional), and assessment of voiding symptoms and sleep apnea history 2
• Follow-up schedule should include first follow-up at 1-2 months after initiation, subsequent visits every 3-6 months for the first year, then yearly, and monitoring of symptomatic response, voiding symptoms, sleep apnea, digital rectal examination, serum testosterone, PSA, and hematocrit/hemoglobin 2

Cardiovascular Risk Assessment

• The combination of low testosterone and high triglycerides increases cardiovascular risk, and consideration should be given to broader cardiovascular risk assessment, including blood pressure measurement, fasting glucose/HbA1c, complete lipid profile, and assessment for other cardiovascular risk factors 2
• The American Urological Association notes that erectile dysfunction is a risk marker for cardiovascular disease, and recommends assessing for erectile dysfunction 5

Long-term Safety Data

• Long-term safety data on testosterone therapy targeting upper-normal levels is lacking 1, 3
• The FDA has required manufacturers to conduct controlled clinical trials to evaluate cardiovascular outcomes of testosterone therapy 3
• The TRAVERSE trial is following participants for up to 5 years for cardiovascular and prostate safety 3