madman
Super Moderator
Trials and tribulations of testosterone therapy in women: Importance of adhering to the evidence
Sexual health is an important part of women’s lives. When the sexual function is impaired, it can negatively affect the quality of life, self-image, and relationship satisfaction and lead to poorer health outcomes.1,2 As many as 43.1% of women of all ages report a sexual problem, with 12% of women having or reporting a distressing sexual problem.2 A biopsychosocial approach is ideal for evaluating, diagnosing, and treating women who have sexual dysfunction.3
Testosterone treatment has been found to be effective in select postmenopausal women who are diagnosed with hypoactive sexual desire disorder (HSDD), which is characterized by low sexual desire causing distress.4 However, no US Food and Drug Administration (FDA)-approved formulation of testosterone is available for women in the United States, due to its unknown long-term safety.
This has not stopped many physicians and other medical practitioners from prescribing custom-compounded or dose-reduced male products to women.5 Some prescribers have shared partial truths through Internet-based marketing to support “bioidentical” testosterone as a “natural” hormone, free of risk and with unfounded benefits,6 making it difficult for women to know whom to trust and where to go regarding their sexual health concerns.
In this issue of the Cleveland Clinic Journal of Medicine, Smith, and Batur7 provide a comprehensive review of the effects of androgens in women, as well as clinically relevant best practice recommendations for the use of androgens in women. They discuss the different types of endogenous androgens and how they interact with various biologic systems in women. They appropriately highlight how a state of “female androgen insufficiency” has not been established in women, such as exists for men, as low serum androgen levels do not reliably correlate with symptoms such as chronic fatigue or decreased mood in women. They also discuss the difficulty of accurately measuring testosterone levels, including pointing out that salivary testing is not recommended for clinical use.
■ LABELS MATTER: DESIRE VS AROUSAL
Nomenclature from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition specifies the category of female sexual dysfunction called female sexual interest and arousal disorder (FSIAD),8 which may be useful for psychiatry or behavioral health practitioners, but does not have support from clinical data nor practicality in the clinical settings in which practitioners manage sexual problems.
Based on the published evidence, reputable organizations such as the Fourth International Consultation on Sexual Medicine and the International Society for the Study of Women’s Sexual Health have clearly stated that desire and arousal are distinct conditions. Thus, the nomenclature and diagnostic criteria for HSDD and FSIAD must remain separate when diagnosing, treating, and coding female sexual dysfunction.9,10 In fact, the female sexual health outcome evaluated in the studies demonstrating the efficacy of testosterone in postmenopausal women was not FSIAD, but rather sexual satisfaction, sexual desire, or HSDD.
■ NEW PUBLICATIONS
Recently, the Global Consensus Position Statement on the Use of Testosterone Therapy for Women was published and endorsed by many respected US and international organizations such as the International Menopause Society, the Endocrine Society, the North American Menopause Society, and the International Society for the Study of Women’s Sexual Health.11 One of its evidence-based and expert-supported recommendations is that the only indication for the use of testosterone in women is for treatment of postmenopausal women who have been diagnosed with HSDD and that the dosage should approximate a normal physiologic level of testosterone for a premenopausal woman.
Importantly, the Global Consensus Position Statement recommends against compounded bioidentical testosterone therapy in view of lack of evidence of efficacy and safety and cautioned against testosterone pellets or injections, which typically result in supraphysiologic concentrations. Those levels may lead to long-term, irreversible side effects including voice changes and clitoromegaly.
■ ALIGNING PRACTICE WITH EVIDENCE
It is important for physicians and other healthcare practitioners caring for women to ensure that their practice aligns with the evidence regarding testosterone treatment for women. There is a great need for comprehensive sexual health treatment, given the significant numbers of women suffering from sexual problems. For those select women with HSDD, transdermal testosterone, properly dosed and monitored, can provide important improvements in quality of life and sexual function.
Testosterone should not be touted as a treatment for improving energy, well-being, or other outcomes that are not supported by data, especially with formulations that put women at risk of supraphysiologic levels. Smith and Batur’s review provides a clinically relevant and valuable summary to communicate this important message.
Sexual health is an important part of women’s lives. When the sexual function is impaired, it can negatively affect the quality of life, self-image, and relationship satisfaction and lead to poorer health outcomes.1,2 As many as 43.1% of women of all ages report a sexual problem, with 12% of women having or reporting a distressing sexual problem.2 A biopsychosocial approach is ideal for evaluating, diagnosing, and treating women who have sexual dysfunction.3
Testosterone treatment has been found to be effective in select postmenopausal women who are diagnosed with hypoactive sexual desire disorder (HSDD), which is characterized by low sexual desire causing distress.4 However, no US Food and Drug Administration (FDA)-approved formulation of testosterone is available for women in the United States, due to its unknown long-term safety.
This has not stopped many physicians and other medical practitioners from prescribing custom-compounded or dose-reduced male products to women.5 Some prescribers have shared partial truths through Internet-based marketing to support “bioidentical” testosterone as a “natural” hormone, free of risk and with unfounded benefits,6 making it difficult for women to know whom to trust and where to go regarding their sexual health concerns.
In this issue of the Cleveland Clinic Journal of Medicine, Smith, and Batur7 provide a comprehensive review of the effects of androgens in women, as well as clinically relevant best practice recommendations for the use of androgens in women. They discuss the different types of endogenous androgens and how they interact with various biologic systems in women. They appropriately highlight how a state of “female androgen insufficiency” has not been established in women, such as exists for men, as low serum androgen levels do not reliably correlate with symptoms such as chronic fatigue or decreased mood in women. They also discuss the difficulty of accurately measuring testosterone levels, including pointing out that salivary testing is not recommended for clinical use.
■ LABELS MATTER: DESIRE VS AROUSAL
Nomenclature from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition specifies the category of female sexual dysfunction called female sexual interest and arousal disorder (FSIAD),8 which may be useful for psychiatry or behavioral health practitioners, but does not have support from clinical data nor practicality in the clinical settings in which practitioners manage sexual problems.
Based on the published evidence, reputable organizations such as the Fourth International Consultation on Sexual Medicine and the International Society for the Study of Women’s Sexual Health have clearly stated that desire and arousal are distinct conditions. Thus, the nomenclature and diagnostic criteria for HSDD and FSIAD must remain separate when diagnosing, treating, and coding female sexual dysfunction.9,10 In fact, the female sexual health outcome evaluated in the studies demonstrating the efficacy of testosterone in postmenopausal women was not FSIAD, but rather sexual satisfaction, sexual desire, or HSDD.
■ NEW PUBLICATIONS
Recently, the Global Consensus Position Statement on the Use of Testosterone Therapy for Women was published and endorsed by many respected US and international organizations such as the International Menopause Society, the Endocrine Society, the North American Menopause Society, and the International Society for the Study of Women’s Sexual Health.11 One of its evidence-based and expert-supported recommendations is that the only indication for the use of testosterone in women is for treatment of postmenopausal women who have been diagnosed with HSDD and that the dosage should approximate a normal physiologic level of testosterone for a premenopausal woman.
Importantly, the Global Consensus Position Statement recommends against compounded bioidentical testosterone therapy in view of lack of evidence of efficacy and safety and cautioned against testosterone pellets or injections, which typically result in supraphysiologic concentrations. Those levels may lead to long-term, irreversible side effects including voice changes and clitoromegaly.
■ ALIGNING PRACTICE WITH EVIDENCE
It is important for physicians and other healthcare practitioners caring for women to ensure that their practice aligns with the evidence regarding testosterone treatment for women. There is a great need for comprehensive sexual health treatment, given the significant numbers of women suffering from sexual problems. For those select women with HSDD, transdermal testosterone, properly dosed and monitored, can provide important improvements in quality of life and sexual function.
Testosterone should not be touted as a treatment for improving energy, well-being, or other outcomes that are not supported by data, especially with formulations that put women at risk of supraphysiologic levels. Smith and Batur’s review provides a clinically relevant and valuable summary to communicate this important message.
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