Is Testosterone Replacement Therapy (TRT) beneficial in perimenopausal women?

Testosterone Replacement Therapy in Perimenopausal Women

Testosterone replacement therapy (TRT) is not recommended for perimenopausal women due to insufficient evidence regarding its safety and efficacy, and it is not FDA-approved for this indication. 1

Evidence on TRT in Perimenopausal Women

• Current guidelines from the U.S. Preventive Services Task Force (USPSTF) recommend against routine use of hormone therapy, including testosterone combinations, for the primary prevention of chronic conditions in perimenopausal women 2
• The FDA has not approved testosterone therapy for use in women, as indicated by the absence of female indications in testosterone product labeling 1
• Limited research shows potential benefits of testosterone therapy in specific circumstances, but these are outweighed by safety concerns and lack of long-term data 3

Potential Benefits of TRT in Perimenopausal Women

• Some evidence suggests testosterone therapy may improve sexual function in postmenopausal women with hypoactive sexual desire disorder, particularly after oophorectomy 4
• One study in premenopausal women with low libido showed improvements in well-being, mood, and sexual function with transdermal testosterone therapy 5
• Testosterone therapy has been associated with improved sense of well-being with transdermal administration (fair evidence) and reduction in triglyceride levels with methyl testosterone (fair evidence) 3

Risks and Safety Concerns

• The most consistent risk of testosterone therapy is reduction in HDL cholesterol levels, particularly with methyl testosterone (good evidence) 3
• There is insufficient data regarding other potential side effects of testosterone therapy in women, including cardiovascular risks, breast cancer risk, and thromboembolic events 6
• Common adverse effects include hirsutism and acne, which typically reverse with discontinuation of treatment 7
• The FDA specifically warns against the use of testosterone in women under section 5.7 of the prescribing information 1

Current Recommendations and Guidelines

• The North American Menopause Society states that testosterone therapy without concomitant estrogen therapy cannot be recommended due to lack of evidence 6
• Hormone therapy of any kind is not recommended for the prevention of chronic conditions such as cardiovascular disease, osteoporosis, or dementia 8, 9
• For management of menopausal symptoms, guidelines recommend FDA-approved formulations with evidence-based approaches rather than testosterone therapy 10

Algorithm for Managing Perimenopausal Symptoms

1. Assess menopausal status and symptom severity 10
2. For vasomotor symptoms (hot flashes) or genitourinary symptoms, consider FDA-approved hormone therapy options rather than testosterone 10
3. For women with an intact uterus requiring hormone therapy, use estrogen plus progestin rather than estrogen plus androgen combinations 9
4. Use the lowest effective dose for the shortest possible time if hormone therapy is necessary 10
5. For sexual dysfunction specifically, rule out causes not related to hormone levels (physical and psychosocial factors, medications) before considering any hormone therapy 6

Common Pitfalls to Avoid

• Initiating testosterone therapy solely for prevention of chronic conditions like osteoporosis or cardiovascular disease 9
• Using custom-compounded testosterone products, which may have inconsistent dosing compared to government-approved products 6
• Using testosterone products formulated for men, which carry a risk of excessive dosing even when used at lower doses 6
• Failing to discuss both potential benefits and risks of testosterone therapy with patients 10