What is the recommended dosing regimen for injectable testosterone (Testosterone) in postmenopausal women with hypoactive sexual desire disorder (HSDD)?

Injectable Testosterone Dosing for Postmenopausal Women with HSDD

Injectable testosterone is not the recommended route of administration for treating HSDD in postmenopausal women; transdermal testosterone is the preferred formulation, but if injectable testosterone must be used off-label, careful dose reduction from male formulations is required with close monitoring to maintain physiologic premenopausal testosterone levels.

Preferred Route of Administration

• Transdermal testosterone is the evidence-based, recommended route for treating HSDD in postmenopausal women, not injectable formulations 1, 2.
• The International Society for the Study of Women's Sexual Health clinical practice guideline specifically endorses systemic transdermal testosterone as the appropriate delivery method 1, 2.
• Randomized controlled trials demonstrating efficacy and safety have used transdermal patches and gels, not injectable formulations 3, 4.

Injectable Testosterone: Critical Limitations

• The FDA-approved injectable testosterone cypionate dosing (50-400 mg every 2-4 weeks) is designed exclusively for hypogonadal males and would result in supraphysiologic levels in women 5.
• Injectable formulations are problematic because they produce fluctuating testosterone levels that are difficult to titrate to the physiologic premenopausal range required for women 1, 2.
• Compounded products, including injectable formulations specifically marketed for women, cannot be recommended due to lack of efficacy and safety data 1, 2.

If Injectable Testosterone Must Be Used (Off-Label)

Dosing Approach

• Government-approved male transdermal formulations can be used cautiously with dosing appropriate for women; this same principle would apply to injectable forms, requiring substantial dose reduction from male dosing 1, 2.
• The goal is to maintain total testosterone concentrations in the physiologic premenopausal range (approximately 15-70 ng/dL), which would require doses far below the 50-400 mg male range 1, 2.
• A reasonable starting approach would be approximately 5-10 mg of testosterone cypionate every 2-4 weeks, though this lacks specific evidence and requires individualized titration 1, 2.

Mandatory Monitoring

• Obtain baseline total testosterone level before initiating therapy (not for diagnosis, but for monitoring purposes) 1, 2.
• Monitor total testosterone levels at regular intervals to ensure levels remain in the physiologic premenopausal range and avoid supraphysiologic dosing 1, 2.
• Assess for signs of androgen excess including acne, increased hair growth, voice deepening, and clitoral enlargement at each visit 1, 3, 2.

Patient Selection and Counseling

• Testosterone therapy is indicated only for postmenopausal women with HSDD not primarily related to modifiable factors such as relationship problems, mental health issues, or other comorbidities 1, 2.
• Informed consent is mandatory before initiating therapy, discussing off-label use, lack of FDA approval for women, benefits, risks, and absence of long-term safety data 1, 2.
• Limited data also support use in late reproductive age premenopausal women, though the primary evidence base is for postmenopausal women 1, 2.

Safety Considerations

• Short-term safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established, particularly regarding cardiovascular risk and breast cancer incidence 1, 6, 2.
• Interim data from long-term trials demonstrate a continued low rate of cardiovascular events and breast cancer in postmenopausal women at increased cardiovascular risk 3.
• The main side effects in clinical trials were increased hair growth and acne 3.

Common Pitfalls to Avoid

• Do not use male dosing ranges for injectable testosterone in women—this will result in dangerous supraphysiologic levels 5, 1.
• Do not use total testosterone levels to diagnose HSDD—low testosterone does not define the condition; use levels only for baseline and monitoring 1, 2.
• Do not prescribe compounded testosterone products—they lack quality control, efficacy data, and safety data 1, 2.
• Do not initiate testosterone without first addressing modifiable contributors to sexual dysfunction including relationship issues, depression, anxiety, and medication side effects 1, 2.

Alternative Considerations

• For postmenopausal women with HSDD, consider FDA-approved alternatives including flibanserin (though studied primarily in premenopausal women) or bremelanotide 7, 8.
• For concurrent dyspareunia, intravaginal DHEA (prasterone) is FDA-approved and may improve sexual function 9.
• Vaginal testosterone cream has been studied in cancer survivors and may be safer than systemic administration for some patients 9.