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Clinical Practice Guidelines for the Use of Testosterone in Women
By: Juliana M. Kling, MD, MPH; Sharon J. Parish, MD | Posted on: 01 Oct 2022
Distressing decreased sexual desire impacts an estimated 12% of women aged 45 to 64 in the United States.1 Hypoactive sexual desire disorder (HSDD) is a clinical diagnosis that includes recurrent or persistent reduction or absence of sexual thoughts or fantasies and is accompanied by significant distress that is not explained by a psychiatric or general medical condition.2 While the DSM-5 and DSM-5-TR have combined sexual desire and interest disorders in the diagnosis of female sexual arousal and interest disorder (FSAID), HSDD is still considered a diagnosis that can be utilized for clinical management, particularly when considering medication treatment.3
Evaluation for HSDD should include a thorough history that incorporates asking about biopsychosocial factors and other domains of sexual functioning including arousal, orgasm, and pain, as well as a gynecologic examination and laboratory testing when indicated.4 The biopsychosocial clinical assessment will assist in the identification, modification, and management of contributing factors and should be done before pharmacotherapy is considered.
For premenopausal women with HSDD, 2 U.S. Food and Drug Administration-approved treatments are available (flibanserin and bremelanotide), while no U.S. Food and Drug Administration-approved treatments are available for postmenopausal women with HSDD. However, testosterone, a steroid hormone that modulates sexual behavior, has evidence to support its efficacy in the treatment of HSDD in postmenopausal women.5 Transdermal testosterone has been shown to improve sexual desire and reduces sexually associated personal distress in menopausal women diagnosed with HSDD with and without concurrent hormone therapy.5 No testosterone serum level correlates with the presence or absence of HSDD or its severity, but there is a correlation between testosterone concentration during therapy and improvement in sexual dysfunction. No serious adverse events have been seen with physiological testosterone use, but there is a lack of data showing long-term safety. Potential side effects of supraphysiological testosterone includes hair growth, acne, voice deepening, and alopecia. Two recent position statements provide guidance to clinicians regarding the use of testosterone for the treatment of HSDD in postmenopausal women: the Global Position Statement on the Use of Testosterone Therapy for Women and the ISSWSH (International Society for the Study of Women’s Sexual Health) Clinical Practice Guideline.6,7
These guidelines both provide practical clinical guidance regarding the use of testosterone in postmenopausal women, including formulation, dose, and monitoring. Since there are no testosterone formulations for women approved by U.S. national drug regulatory authorities, off-label use of approved formulations for men are used for women at approximately a tenth of the standard dose for men. The most physiological form of replacement therapy is transdermal, and intramuscular injections and subcutaneous implants should be avoided since they result in supraphysiological levels. Oral preparations such as troches or lozenges are not recommended because of possible adverse lipid effects, such as a reduction in high-density lipoprotein cholesterol and increase in low-density lipoprotein cholesterol. Dosing should aim to achieve testosterone concentrations in a physiological premenopause range. It is important that patients receive informed consent prior to initiation of treatment, with a comprehensive discussion of off-label use as well as benefits and risks. In addition, baseline total testosterone levels should be obtained to exclude women with midrange to high values at the onset of therapy, as well as baseline liver function and lipid panel to assure they are in a normal range.
There is no blood level that is used as a treatment target, but a repeat level should be measured 3-6 weeks after initiation to assure the total testosterone remains in a physiological range. For women who do not notice improvement in their HSDD after 6 months of use, testosterone can be stopped. If it is continued, then annual evaluations should be done that include monitoring of lipids, liver function tests, and complete blood count, as well as breast and pelvic examinations and mammography.
Ideally in the future, U.S. national drug authorities will authorize a testosterone formulation for women suffering from HSDD. In the interim, clinicians can utilize the recent Global Position Statement and ISSWSH Clinical Practice Guideline which succinctly summarize the research on testosterone, its benefits, and an evidence-based practical approach to treating postmenopausal women with HSDD with testosterone therapy.
- Shifren J, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112(5):970-978.
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (5th ed.). 2013.
- Parish SJ, Goldstein AT, Goldstein SW, et al. Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions—part II. J Sex Med. 2016;13(12):1888-1906.
- Clayton A, Goldstein I, Kim NN, et al. The International Society for the Study of Women’s Sexual Health process of care for management of hypoactive sexual desire disorder in women. Mayo Clin Proc. 2018;93(4):467-487.
- Islam RM, Bell RJ, Green S, Page MJ, Davis SR. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol. 2019;7(10):754-766.
- Davis SR, Baber R, Panay N, et al. Global consensus position statement on the use of testosterone therapy for women. Climacteric. 2019;22(5):429-434.
- Parish SJ, Simon JA, Davis SR, et al. International Society for the Study of Women’s Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2021:18(5);849-867.