Androgel (Testosterone) in Perimenopause
Androgel (testosterone) is not recommended as a treatment for perimenopausal women due to lack of FDA approval for this indication, limited evidence supporting its use, and potential safety concerns. 1, 2
Current Evidence and Recommendations
Testosterone therapy, including Androgel, lacks sufficient evidence to support its routine use in perimenopausal women:
- The Endocrine Society, American Congress of Obstetricians and Gynecologists, American Society for Reproductive Medicine, European Society of Endocrinology, and International Menopause Society all recommend against the general use of testosterone for women except in very specific circumstances 2
- Current guidelines recommend against testosterone use for general well-being, cognitive function, cardiovascular health, metabolic health, or bone health in women 2
- There is no FDA approval for testosterone products specifically designed for women in the United States 2, 3
Potential Risks of Testosterone in Women
Testosterone therapy carries significant risks that outweigh potential benefits in perimenopausal women:
- Cardiovascular risks: Testosterone may increase risk of major adverse cardiovascular events (MACE) including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death 4
- Venous thromboembolism: Increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) 4
- Polycythemia: Increases in hematocrit requiring monitoring and potential discontinuation 4
- Virilizing effects: Hirsutism and acne are common side effects 2, 5
- Potential for abuse: Testosterone has been subject to abuse, typically at doses higher than recommended 4
- Edema: May promote retention of sodium and water 4
- Lipid profile changes: May require dose adjustment or discontinuation 4
Limited Circumstances Where Testosterone May Be Considered
While not recommended for general perimenopause management, testosterone therapy has limited evidence for specific conditions:
- Hypoactive sexual desire disorder (HSDD) in postmenopausal women (not perimenopausal) with personal distress and no other identifiable cause 3, 5
- Even in these cases, treatment should only be considered after ruling out other causes and with close monitoring 5
Recommended Alternatives for Perimenopause Management
Instead of testosterone therapy, current guidelines recommend:
- Oral micronized progesterone (300 mg at bedtime) as a first-line option for many perimenopausal symptoms 1
- SNRIs or SSRIs (except paroxetine in women who might use tamoxifen later) 1
- Gabapentin for vasomotor symptoms 1
- Lifestyle modifications including regular exercise, stress reduction techniques, and dietary adjustments 1
- For women with vaginal symptoms, non-hormonal moisturizers and lubricants or localized vaginal treatments may be appropriate 6
Monitoring Requirements If Testosterone Is Used
If testosterone therapy is considered despite these recommendations:
- Regular monitoring for signs and symptoms of androgen excess 2
- Hematocrit should be checked prior to initiating treatment, 3-6 months after starting, and then annually 4
- Monitoring for cardiovascular events, venous thromboembolism, and lipid profile changes 4
- Laboratory testing of testosterone levels to monitor for supraphysiologic levels 5
- Subjective assessments of sexual response, desire, and satisfaction 5
Conclusion
Based on current guidelines and available evidence, Androgel (testosterone) is not recommended for perimenopausal women. The lack of FDA approval, limited evidence for efficacy, and potential safety concerns outweigh any potential benefits. Healthcare providers should consider recommended alternatives for managing perimenopausal symptoms.