From the Guidelines
The use of testosterone in women should be approached with caution, and according to the most recent study, a small study of postmenopausal survivors of hormone receptor (HR)–positive breast cancer receiving aromatase inhibitor (AI) therapy found that intravaginal testosterone cream was safe and improved vaginal atrophy and sexual function 1. When considering testosterone therapy in women, it is essential to weigh the potential benefits against the risks. The safety considerations for using testosterone in women include monitoring for masculinizing side effects, such as acne, hirsutism, deepening voice, clitoromegaly, and male-pattern baldness. Some key points to consider when using testosterone in women include:
- Regular monitoring of testosterone levels to maintain levels within the upper normal female range
- Blood tests every 3-6 months initially, then annually, including lipid profiles and liver function tests
- Screening for cardiovascular risk factors before starting therapy
- Contraindication during pregnancy and breastfeeding, and the use of reliable contraception in women of reproductive age
- Monitoring for polycythemia through complete blood counts
- Using lower doses than those used for men, such as 2-4 mg testosterone gel daily or 50-100 mg implants every 3-6 months
- Discontinuing treatment if significant adverse effects occur or if benefits are not achieved after 6 months of therapy It is crucial to note that the safety data for the use of androgen-based therapy in survivors of hormonally mediated cancers are limited, and testosterone should be used with caution in survivors receiving AI therapy, as it may impact AI activity 1.
From the FDA Drug Label
5.7 Use in Women
The safety of using testosterone in women is a concern due to the potential for virilizing effects.
- Key safety considerations for using testosterone in women include:
- Monitoring for signs of virilization, such as hirsutism, acne, and deepening of the voice
- Regular evaluation of liver function and lipid profiles
- Assessment of cardiovascular risk factors The FDA drug label advises caution when prescribing testosterone to women, and recommends careful monitoring for potential adverse effects 2.
From the Research
Safety Considerations for Testosterone Use in Women
The safety of using testosterone in women is a topic of ongoing research and debate. Several studies have investigated the potential risks and benefits of testosterone therapy in women, particularly in the context of hypoactive sexual desire disorder.
- Short-term safety: Studies have shown that short-term use of testosterone in women, up to 2 years, does not increase the risk of hepatotoxicity, endometrial hyperplasia, or behavioral hostility 3.
- Cardiovascular effects: No adverse cardiovascular effects, including changes in blood pressure, blood viscosity, arterial vascular reactivity, hypercoagulable states, and polycythemia, have been reported in short-term studies 3.
- Breast cancer risk: The data on breast cancer risk is mixed, with some studies suggesting a decrease in estrogen-induced breast epithelial proliferation with low-dose testosterone, while others have found no increased risk of breast cancer in models of superphysiologic testosterone levels, such as polycystic ovarian disease 3.
- Side effects: Common side effects of testosterone therapy in women include mild and reversible acne, hirsutism, and changes to the lipid profile with oral, but not transdermal, testosterone 3, 4.
- Long-term safety: Long-term safety data on testosterone use in women is lacking, and more research is needed to fully understand the potential risks and benefits of testosterone therapy in this population 3, 5.
Testosterone Therapy in Postmenopausal Women
Testosterone therapy has been shown to improve sexual function in postmenopausal women with hypoactive sexual desire disorder, particularly after oophorectomies 4.
- Efficacy: Randomized trials have demonstrated an improvement in sexual function with testosterone in postmenopausal women with hypoactive sexual desire disorder 4.
- Safety: Side effects have been well tolerated and reversible upon discontinuation, and transdermal patches and topical gels are preferred formulations due to their avoidance of hepatic first-pass metabolism 4.
- Monitoring: Women receiving testosterone should be monitored for clinical improvement and adverse reactions, and testosterone therapy is usually administered concomitantly with estrogen therapy due to a lack of adequate safety and efficacy data on testosterone alone 4.
Special Considerations
In certain populations, such as fragile X carrier females, low-dose testosterone has been shown to be a safe and effective approach in treating hypoactive sexual desire disorder, provided the patient is monitored regularly for blood counts, lipid profiles, liver functions, and free and total testosterone levels 6.