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Androgen Therapy in Women: An Endocrine Society Clinical Practice Guideline
Open accessAbstract
OBJECTIVE: The objective was to provide guidelines for the therapeutic use of androgens in women. PARTICIPANTS: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee (CGS) of The Endocrine Society, six additional experts, a methodologist, and a medical writer. The Task Force received no corporate funding or remuneration. EVIDENCE: The Task Force used systematic reviews of available evidence to inform its key recommendations. The Task Force used consistent language and graphical descriptions of both the strength of recommendation and the quality of evidence, using the recommendations of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) group. The strength of a recommendation is indicated by the number 1 (strong recommendation, associated with the phrase "we recommend") or 2 (weak recommendation, associated with the phrase "we suggest"). The quality of the evidence is indicated by cross-filled circles, such that [1 cross-filled circle, 3 empty circles] denotes very-low-quality evidence, [2 cross-filled circles, 2 empty circles] low quality, [3 cross-filled circles, 1 empty circle] moderate quality, and [4 cross-filled circles] high quality. Each recommendation is followed by a description of the evidence. CONSENSUS PROCESS: Consensus was guided by systematic reviews of evidence and discussions during one group meeting, several conference calls, and e-mail communications. The drafts prepared by the task force with the help of a medical writer were reviewed successively by The Endocrine Society's CGS, Clinical Affairs Committee (CAC), and Executive Committee. The version approved by the CGS and CAC was placed on The Endocrine Society's web site for comments by members. At each stage of review, the Task Force received written comments and incorporated needed changes. CONCLUSIONS: We recommend against making a diagnosis of androgen deficiency in women at present because of the lack of a well-defined clinical syndrome and normative data on total or free testosterone levels across the lifespan that can be used to define the disorder. Although there is evidence for short-term efficacy of testosterone in selected populations, such as surgically menopausal women, we recommend against the generalized use of testosterone by women because the indications are inadequate and evidence of safety in long-term studies is lacking. A review of the data currently available is presented, and areas of future research are outlined. To formulate clinical guidelines for use of testosterone in women, additional information will be necessary. This includes defining conditions that, when not treated with androgens, have adverse health consequences to women; defining clinical and laboratory parameters that distinguish those with these conditions; and assessing the efficacy and long-term safety of androgen administration on outcomes that are important to women diagnosed with these conditions. This necessary clinical research cannot occur until the biological, physiological, and psychological underpinnings of the role of androgens in women and candidate disorders are further elucidated.
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“Currently, there is no consensus as to the accepted lower T limits or established reference intervals.”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [93]
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“Further, androgen deficiency in women is not well-defined and thus should not be diagnosed until normative data on testosterone levels across a woman’s lifespan have been established (17).”
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MethodInfluentialSelf-citationA Mindfulness-Based Group Psychoeducational Intervention Targeting Sexual Arousal Disorder in Women
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“In particular, immunoassays are affected by cross-reactivity with other steroids (Middle, 2007; Benton et al., 2011) and by high levels of SHBG (Masters and Hahnel, 1989; Wierman et al., 2006).”
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Bhasin, S., Enzlin, P., Coviello, A. D., & Basson, R. J. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60280-3 · Cited by 319
Self-citationIncreased risk of parkinsonism in women who underwent oophorectomy before menopause
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“In addition to progesterone, androgen levels also decrease during the menopausal transition (34) and could contribute to bone loss.”
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Brotto, L. A., Bitzer, J., Laan, E. T. M., Leiblum, S. R., & Luria, M. (2010) · The Journal of Sexual Medicine · doi:10.1111/j.1743-6109.2009.01630.x · Cited by 216
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“Women with elevated androgen levels, whether endogenous or exogenous, experience breast atro phy consistent with the notion that androgens, per se, are anti-proliferative for the breast (Wierman et al., 2006).”
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Rocca, W. A., Grossardt, B. R., Geda, Y. E., Gostout, B. S., Bower, J. H., Maraganore, D. M., de Andrade, M., & Melton, L. J. (2018) · Menopause The Journal of The North American Menopause Society · doi:10.1097/gme.0000000000001229 · Cited by 169
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(2012) · Journal of Obstetrics and Gynaecology Canada · doi:10.1016/s1701-2163(16)35359-2 · Cited by 170
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“…in 2006 recommend against making a diagnosis of androgen deficiency in women with normal adrenal function because of the lack of a clearly defined clinical syndrome, and of normative data on testosterone levels across women’s lifespan that can be used to define the disorder (Wierman et al., 2006).”
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“women (Wierman et al., 2006) or after breast cancer (Barton et al.”
Long-term risk of depressive and anxiety symptoms after early bilateral oophorectomy
Rocca, W. A., Grossardt, B. R., Geda, Y. E., Gostout, B. S., Bower, J. H., Maraganore, D. M., de Andrade, M., & Melton, L. J. (2008) · Menopause The Journal of The North American Menopause Society · doi:10.1097/gme.0b013e318174f155 · Cited by 154
“However, the effect of progesterone and testosterone on psychiatric symptoms in women remains uncertain.(28,29) Third, the association between oophorectomy and increased risk of depressive or anxiety symptoms may be due to one or several susceptibility genes that increase the risk of both outcomes independently (ie, c…”
BackgroundVesper, H. W., Bhasin, S., Wang, C., Tai, S. S., Dodge, L. A., Singh, R. J., Nelson, J., Ohorodnik, S., Clarke, N. J., Salameh, W. A., et al. (2009) · Steroids · doi:10.1016/j.steroids.2009.01.004 · Cited by 152
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“significantly under-researched, as recently acknowledged by a task force of The Endocrine Society [148].”
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“The hypothesis of a neuroprotective effect of progesterone and testosterone is corroborated by several laboratory and clinical studies [23,25,26,44,51,52].”
ResultRevisiting the role of testosterone: Are we missing something?
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“Some clinical studies suggest that DHEA may have some activity on mood and behavior [137, 138], but this remains controversial [139] and DHEA replacement therapy is not yet standard-of-care [140].”
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“the use of androgen therapy in women—for example, between the Endocrine Society clinical practice guidelines (against) [120] and the North American Menopause Neurobiology of Female Sexual Response, and Agents for Treatment of HSDD”
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Self-citationDavis, S. R., & Braunstein, G. D. (2012) · The Journal of Sexual Medicine · doi:10.1111/j.1743-6109.2011.02634.x · Cited by 123
Self-citationChanges in pituitary function with ageing and implications for patient care
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“Testosterone therapy is offered by some clinicians for HSDD but its safety and efficacy have not been well established [120] in healthy women or after breast cancer [121].”
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“In recent years, a number of therapeutic protocols have included androgens as part of the traditional postmenopausal hormonal therapy [1,2], although there are few efficacy data.”
BackgroundWomen's sexual function and dysfunction: current uncertainties, future directions
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“We are unaware of evidence that testosterone improves clinically relevant outcomes, such as physical performance or cognitive function, in older women (35, 37).”
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“In addition to progesterone, androgen levels also decrease during the menopausal transition (3) and could contribute to bone”
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Self-citationThe varied nature of women's sexuality: Unresolved issues and a theoretical approach
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“Eligible studies prior to July 2008 were identified from previous Endocrine Society guidelines (20), from a previously published systematic review addressing the same question by the Cochrane collaboration (21), and from a review about T without HRT (7).”
Androgens and the Regulation of Adiposity and Body Fat Distribution in Humans
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Managing female sexual dysfunction
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“Consensus reports from the Endocrine Society and the North American Menopause Society were initially cautionary (47, 48).”
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“Currently, there is inadequate evidence from long-term studies for the safety and efficacy of androgen therapy, thus recent guidelines recommend against their use in women [ 67 ].”
BackgroundTestosterone Treatment for Hypoactive Sexual Desire Disorder in Postmenopausal Women
Kingsberg, S. A. (2007) · The Journal of Sexual Medicine · doi:10.1111/j.1743-6109.2007.00449.x · Cited by 80
Inder, W. J., Jang, C., Obeyesekere, V. R., & ALFORD, F. P. (2009) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2009.03683.x · Cited by 78
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“Graded as low quality when there is moderate quality evidence for benefits 8 Additional research We recommend additional investigation using rodents and primates to further define the specific targets of androgen action (16) 5 (4)”
BackgroundSalonia, A., Pontillo, M., Nappi, R. E., Zanni, G. E., Fabbri, F., Scavini, M., Daverio, R., Andrea Gallina, A., Rigatti, P., Bosi, E., et al. (2008) · The Journal of Sexual Medicine · doi:10.1111/j.1743-6109.2008.00791.x · Cited by 77
Testosterone, SHBG and cardiovascular health in postmenopausal women
Brand, J. S., & van der Schouw, Y. T. (2010) · International Journal of Impotence Research · doi:10.1038/ijir.2009.64 · Cited by 73
“17 These findings have raised questions regarding the safety of testosterone administration to postmenopausal women”
BackgroundAndrogens, health and sexuality in women and men
Wylie, K. R., REES, M. C. P., Hackett, G. I., Anderson, R. A., Bouloux, P.-M. G., Cust, M., Goldmeier, D., Kell, P. D., TERRY, T. R., TRINICK, T. R., et al. (2010) · Maturitas · doi:10.1016/j.maturitas.2010.07.011 · Cited by 73
“However, although supra-physiological doses of androgens can enhance genital engorgement [46], community-based and clinical studies with”
BackgroundInfluentialSantoro, N. F., Braunstein, G. D., Butts, C. L., Martin, K. A., McDermott, M., & Pinkerton, J. V. (2016) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2016-1271 · Cited by 75
“The preponderance of current data do not indicate that treating postmenopausal women to restore testosterone levels to those that normally occur in young reproductive females results in adverse cardiovascular, endometrial, or breast effects (94).”
BackgroundMethodInfluentialSelf-citationSexual dysfunction assessment and hormonal correlations in patients with polycystic ovary syndrome
Ercan, C. M., Çoksüer, H., Aydoğan, Ü., Alanbay, İ., Keskin, U., Karaşahin, K. E., & Basȩr, Ï. (2013) · International Journal of Impotence Research · doi:10.1038/ijir.2013.2 · Cited by 71
Androgen replacement therapy in Turner syndrome: a pilot study
Zuckerman-Levin, N., Frolova-Bishara, T., Militianu, D., Levin, M., Aharon-Peretz, J., & Hochberg, Z. (2009) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-0514 · Cited by 69
“Recognizing the limitation in testosterone assays in women (16, 28), TS subjects of this study had low normal serum total testosterone, and its level increased on ART but remained in the normal range for women.”
BackgroundMethodAndrogen therapy for loss of desire in women: is the benefit worth the breast cancer risk?
Schover, L. R. (2007) · Fertility and Sterility · doi:10.1016/j.fertnstert.2007.05.057 · Cited by 69
“In 2003, the last year that sales figures were available, United States sales of DHEA totaled $47 million (10).”
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Erichsen, M. M., Husebye, E. S., Michelsen, T. M., Dahl, A. A., & Løvås, K. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2010-0445 · Cited by 66
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“benefit from testosterone supplementation, at least in the short term (Wierman et al., 2006).”
BackgroundEndocrine disorders and fertility and pregnancy: An update
Bednarska‐Czerwińska, A., Zmarzły, N., Morawiec, E., Panfil, A., Bryś, K., Czarniecka, J., Остенда, А., Dziobek, K., Sagan, D., Boroń, D., et al. (2023) · Frontiers in Endocrinology · doi:10.3389/fendo.2022.970439 · Cited by 73
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“[16] Wierman ME, Basson R, Davis SR, Khosla S, Miller KK, Rosner W, et al.”
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“It has also been noted that the free testosterone level below which female sexuality might effectively be diminished during the reproductive period remains unclear [19].”
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“Although a biopsychosocial approach to female sexuality remains in order, there seems to be a consensus upon the role of testosterone in motivational aspects of sexuality such as sexual desire (6, 7). Clinicians still wonder under which cut-off levels of free/testosterone complaints of low sexual desire most often occ…”
BackgroundInfluentialGuerrieri, G. M., Martinez, P. E., Klug, S. P., Haq, N., Vanderhoof, V. H., Koziol, D. E., Popat, V., Kalantaridou, S., Calis, K. A., Rubinow, D. R., et al. (2014) · Menopause The Journal of The North American Menopause Society · doi:10.1097/gme.0000000000000195 · Cited by 55
“Because neither measures of depression nor quality of life improved after EPT-plus-testosterone treatment compared with EPT, our data suggest that, in women with POI, neither measure should be an indication for testosterone treatment, in keeping with current Clinical Practice Guidelines.51 The limitations of this stud…”
ResultSexual function in young women with spontaneous 46,XX primary ovarian insufficiency
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“The Endocrine Society has concluded that the female androgen deficiency syndrome is not presently well defined and that clinicians should not make this diagnosis in women until normative data on total and free testosterone levels have been established across the lifespan (31).”
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“However, controversy still exists on the indication of androgen therapy in women.(31) Tibolone and HT with estradiol and noretisterone are other options to improve sexual desire.”
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Self-citationAndrogen therapy in women: for whom and when
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“published setting the position of three societies about androgen therapy in women; the first in 2005 by the North American Menopause Society [16], the second a year later by The Endocrine Society [17] and the last in 2010 by The British Society for Sexual Medicine (BSSM) for the assessment of testosterone deficiency i…”
Androgen Physiology, Pharmacology, and Abuse
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Drug Insight: breast cancer prevention and tissue-targeted hormone replacement therapy
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“There are a number of issues about the interpretation of T values in women being debated (Wierman et al., 2006).”
History of the Treatment of Female Sexual Dysfunction(s)
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“Overall, supraphysiological testosterone administration may be capable of preventing androgen deficiency-related bone loss; however, the sex-specific skeletal responses following testosterone administration require clarification (26, 59).”
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“, 2007) and guidelines (North American Menopause Society, 2005) have advocated a beneficial effect of androgen therapy in hypoandrogenic women, the evidence is controversial and the Endocrine Society Clinical Practice Guidelines do not recommend androgen therapy until the physiological role of androgens has become cle…”
BackgroundOuyang, P., WENGER, N. K., Taylor, D. A., Rich-Edwards, J. W., Steiner, M. S., Shaw, L. J., Berga, S. L., Miller, V. M., & Merz, C. N. B. (2016) · Biology of Sex Differences · doi:10.1186/s13293-016-0073-y · Cited by 54
“Various immunoassay methodologies are commercially available [38, 40, 41].”
Roberts, H. (2007) · BMJ · doi:10.1136/bmj.39153.522535.be · Cited by 49
NOFSA Guideline for the Diagnosis and Management of Osteoporosis
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Sex-Based Differences in Vascular Function
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Approved Hormonal Treatments for HSDD: An Unmet Medical Need
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Metadata
- Authors
- Wierman, M. E., Basson, R., Davis, S. R., Khosla, S., Miller, K. K., Rosner, W., & Santoro, N.
- Affiliations
- University of Colorado Denver (US)
- University of British Columbia (CA)
- The Alfred Hospital (AU)
- Mayo Clinic (US)
- Massachusetts General Hospital (US)
- St. Luke's-Roosevelt Hospital Center (US)
- Albert Einstein College of Medicine (US)
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2006-10-01
- Volume
- 91
- Issue
- 10
- Pages
- 3697-3710
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2118649626
- Cited by
- 301
- References
- 165
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 1 · 2023: 4 · 2022: 6 · 2021: 6 · 2020: 5 · 2019: 8 · 2018: 13 · 2017: 8 · 2016: 17 · 2015: 9 · 2014: 17 · 2013: 13 · 2012: 25
- FWCI
- 24.23
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Keywords
- treatment, androgen therapy, testosterone, women, androgen deficiency, surgical menopause, hormone replacement therapy, long-term safety, quality of evidence, strength of recommendation, menopausal symptoms, cardiovascular risk, bone mineral density, cancer risk, quality of life, sexual function, sleep apnea
- MeSH terms
- Affect, Aging, Anorexia Nervosa, Body Composition, Cognition, Female, Humans, Hypopituitarism, Menopause, Sexual Dysfunction, Physiological, Testosterone, Evidence-Based Medicine
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