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Try out PMC Labs and tell us what you think. Learn More. Aim: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with HSDD. Methods: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women.

Consensus was reached using a modified Delphi method. Outcomes: A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up. : Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD.

Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent.

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Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for s of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data.

Clinical Implications: This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging. Conclusion: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a ificant unmet need.

Testosterone has been an important evidence-based, albeit controversial, therapy for women with hypoactive sexual desire disorder HSDD. Over the past 2 decades, multiple publications consisting of original research, reviews, and meta-analyses have supported the use of testosterone therapy for HSDD in postmenopausal women.

It provided clinical guidance regarding the use of testosterone therapy in women, examining the effect on sexual function; well-being, mood, and cognition; musculoskeletal effects; cardiovascular and breast health; as well as androgenic side effects and adverse events. The conclusions were developed based on the systematic review and meta-analysis of the benefits and risks of testosterone therapy in women, 5 and the clinical practice recommendations were based on the expert opinion and the consensus of the panelists.

According to the Global Position Statement, the sole evidence-based indication for testosterone therapy is HSDD in postmenopausal women, using a biopsychosocial assessment and treatment model. There remains a need for a consensus clinical practice guideline that provides a comprehensive management strategy for the use of systemic testosterone in women with HSDD.

The purpose of the present article is to provide specific recommendations regarding identification of patients, laboratory testing, dosing, monitoring, and follow-up care in the consideration of testosterone therapy for HSDD in women. Government-approved testosterone products for HSDD in women are not currently available in the United States or approved by any national regulatory authority except in Australia.

However, the FDA declined approval based on safety concerns raised by its advisory committee, despite the absence of als supporting those safety concerns in the regulatory submission. Unfortunately, it was withdrawn from the European market by the manufacturer because of poor sales. Therefore, due to the lack of government-approved testosterone products for women, clinicians generally have resorted to using products off-label that are approved for men and compounded formulations without a clear standard of clinical care.

This guideline was developed with the administrative support of the ISSWSH and the contributions from a multidisciplinary panel of international experts. The panel, consisting of 16 researchers and clinicians, who were the ISSWSH members and nonmembers, convened to review and discuss clinical management strategies for the use of testosterone using a modified Delphi method. Where guidance is not provided in the Global Position Statement, ly published guidelines have been used. At the consensus meeting, the panelists presented summaries of the current literature; discussion of testosterone measurement, formulations, and indications for treatment; and developed consensus for this clinical guideline.

HSDD may be primary or secondary, lifelong or acquired, and generalized or situational. The of perimenopausal and postmenopausal women is increasing, and HSDD is a ificant problem in general and of particular concern in this population. Byusing the age of 50 years as a proxy for menopause, the world population of postmenopausal women will be around 1. The terms premature ovarian insufficiency less than age 40 years and early menopause less than age 45 years describe the spectrum of conditions associated with the loss of ovarian function before the age of natural menopause.

Premature ovarian insufficiency and early menopause include both spontaneous primary ovarian insufficiency idiopathic; caused by chromosomal and genetic defects; associated with autoimmune disorders, infections, metabolic disturbances, environmental factors and induced ovarian failure resulting from interventions pelvic radiation therapy, chemotherapy, surgical oophorectomy including risk-reducing bilateral salpingo-oophorectomy in women with BRCA mutations.

Testosterone is a metabolic, vascular, and reproductive hormone in women. Relative production of circulating androgens in the adrenal glands and ovaries. The substantial contribution of androstenedione to circulating testosterone is shown by a dashed arrow and involves peripheral tissue conversion.

Synthetic pathways of sex steroids. Intermediate steps involved in the conversion of cholesterol to DHEA are not shown. The ovaries and adrenal glands have a full complement of enzymes to produce androgens and estrogens. In addition, circulating DHEA can be converted to testosterone and estradiol in peripheral tissues green shaded area. Major pathways of synthesis in humans are denoted by blue arrows, and minor pathways are denoted by gray arrows adapted from Traish et al.

This reaction le to recruitment of transcriptional factors and interaction with receptor coactivators or corepressors resulting in gene activation or repression and modification of cellular metabolism. Nevertheless, the wide expression of the AR in various tissues including the female central nervous system and genital and other reproductive tissues suggest that androgens play an important physiological role in female sexual function.

Androgen receptor AR mechanism of action adapted from Traish et al. Regarding the role of testosterone in sexual desire, correlational data from human studies may be more informative than laboratory studies in animals because the assessment of sexual desire in animal studies is limited to monitoring appetitive behaviors. However, observations from animal studies can provide additional insight.

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In one study of sexually inexperienced female shrews that had low levels of estrogen, testosterone propionate implanted into the medial preoptic area or dorsomedial hypothalamus induced sexual behavior. Gonadectomy le to alterations in hippocampal neuroplasticity that are associated with depressive-like behaviors that can inhibit sexual motivation. The brain is one of the most important targets for sex hormones throughout the life span.

Some research supports the role of estradiol in the central modulation of sexual desire. It remains unclear whether testosterone positively modulates sexual desire in women through a direct stimulation of the AR or through its conversion to estrogen and subsequent binding to estrogen receptors. One is based on the fact that estrogen-alone therapy in postmenopausal women was associated with a small to moderate improvement in sexual function, particularly in pain, with no effect on libido, sexual desire, and interest.

Existing evidence therefore suggests that testosterone conversion into estradiol is not necessary to exert its beneficial effects on sexuality. The peripheral responses in female sexual arousal include genital vasocongestion and vaginal lubrication, which result from increased blood flow to the clitoris, vulva, labia, and vagina. The ARs have been detected throughout genitourinary tissues, such as the vagina, clitoris, labia, vestibule, bladder, and supporting structures of the pelvic floor.

Estradiol modulates genital hemodynamics and is related to the density of collagen fibers in the lamina propria and moderates muscular thickness in the vagina and vasorelaxant mechanisms of the clitoris. Vaginal lubrication is a combination of basal mucin production and vaginal vascular transudate.

Androgens play an important role in genital sexual response. This guideline will address the impact of and indications for systemic testosterone therapy and will not focus on intravaginal androgens. Direct assays measure total testosterone in women using the radioimmunoassay RIA technique. Assays have not been standardized for this purpose at either a national or international level, and total testosterone concentrations may be reported as being substantially different for a single sample by different laboratories.

Hence, direct assays for the measurement of total and free testosterone are highly unreliable in the female range. Androgen levels decline with age and drop abruptly after bilateral oophorectomy. All analyses were adjusted for age, body mass index, cycle stage, smoking, parity, partner status, and psychoactive medication.

These different rates have been attributed to the abrupt loss of ovarian androgen and ificantly greater personal distress in young surgically menopausal women, indicating that testosterone may contribute substantially to sexual desire. A large epidemiological investigation found a poor correlation between any steroid hormone measured by immunoassay and low sexual desire or function.

The lack of clear correlation between sexual function and declining androgen levels has been explained by the complexity of androgen metabolism and measurement 88 and the observation that circulating testosterone levels do not adequately reflect tissue concentrations.

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The complex regulation of AR expression plays a key role in androgen effects. Although no testosterone serum concentration correlates with the presence or absence of HSDD or its severity, 88 there is a loose correlation between testosterone concentration while undergoing treatment and its benefits for improving sexual dysfunction. As testosterone is measured by a variety of methods with different reference standards, it is not possible to establish a universal reference range for premenopausal women.

Historically, the adequacy of serum testosterone therapy targeting premenopausal values was estimated using the free androgen index FAI with assessment of morning total testosterone T and SHBG. An attempt to extend this method for determination of a discriminatory level correlated to sexual function and dysfunction was published by Guay et al. Based on this small cohort, these investigators proposed a clinically useful range of the normal androgen profile in women without sexual dysfunction. The applicability of this method in clinical practice is limited given today's alternatives for several reasons: 1 the small sample sizes of the original publications, 2 insufficient accuracy and precision of RIA testosterone measurements, 9495 3 the availability of better methodology for clinical use, and 4 an improved understanding of the binding characteristics of testosterone in serum across the entire range spectrum.

Although there are limitations with total testosterone measurement in clinical practice, the Global Position Statement and this consensus panel recommend total testosterone as the best available measure, rather than free or bioavailable testosterone or the FAI. Therapy should not target total testosterone concentrations that exceed those of premenopausal women. There is no definitive testosterone cutoff level to identify women with sexual dysfunction including HSDD.

The main reasons to measure testosterone are 1 to exclude women with midrange to high values according to the assay used that would suggest against androgen levels being associated with the patient's symptoms and 2 to monitor testosterone therapy to ensure against supraphysiological values and associated androgen excess side effects.

There is consistent evidence from placebo-controlled randomized clinical trials RCTs that testosterone therapy is more effective than placebo for the treatment of HSDD in postmenopausal women. Women who identified with having clinically meaningful benefit also achieved larger statistically ificant improvements in sexual desire, satisfying sexual activity, and personal distress than those who did not achieve clinically meaningful benefit from the therapy. The data for the effects of testosterone in premenopausal women are limited to women in the late reproductive years.

Although the 3 placebo-controlled RCTs of testosterone in premenopausal women — suggest favorable effects of transdermal testosterone on sexual function in older premenopausal women presenting with low sexual desire, the s of women in each study were small.

A recent meta-analysis demonstrated the need for further research to determine the efficacy of testosterone therapy for premenopausal women with HSDD. Testosterone preparations, specifically IM, subcutaneous implants, and oral formulations methyltestosterone 1. The longest duration placebo-controlled trial 24 months included subjects.

IM administration is associated with wide excursions of serum testosterone concentrations well beyond physiological levels; subcutaneous implants occasionally yield markedly elevated testosterone levels with erratic release over time and difficulty locating for removal if necessary.

Oral testosterone undecanoate was associated with unpredictable absorption and blood levels in the male range, even at the lowest dose studied. In a meta-analysis of 36 trials enrolling 8, women with duration of 12 weeks—2 years, testosterone administration oral preparations in approximately half the trials; IM injection, subcutaneous pellets, and transdermal preparations in the remainder increased the risk of developing acne relative risk 1. Accordingly, a meta-analysis of safety outcomes and adverse events reported from 7 trials, enrolling 3, participants, randomized to transdermal testosterone mcg or placebo, either on or not on estrogen-progestin hormone therapy and followed for 24 weeks found that total androgenic adverse events were increased hazard ratio 1.

Despite these reassuring outcomes, long-term beyond 2 years safety data, particularly regarding breast cancer and cardiovascular events acute myocardial infarction, stroke, deep vein thrombosis, and deathare limited and inconclusive.

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Several recent meta-analyses and the 4-year open-label extension trial provide safety reassurance for the use of transdermal testosterone therapy in postmenopausal women with doses that approximate physiological levels for premenopausal women. One interim approach would be to establish longitudinal observational studies and patient registries to supplement completed RCTs. It would be clinically useful to stratify safety data by menopausal status, ovarian status intact vs oophorectomizedand concurrent estrogen and progestogen therapies.

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As with studies of estrogen and progestin therapies, reassurances of safety would be strengthened with stratification of cardiovascular outcomes venous thromboembolic events, stroke, myocardial infarctionby age, time since menopause, and metabolic characteristics to facilitate advising women at different baseline risk. A summary of the key clinical recommendations for this Clinical Practice Guideline is described in Table 1.

The levels of evidence supporting these key points are discussed in the Global Position Statement. The clinician and the patient should discuss the of the Decreased Sexual Desire Screener to determine the relative importance of these contributors. Recommended strategies also include a detailed sexual history that incorporates information about sexual desire, arousal, orgasm, and pain and other aspects of sexual activity and function as indicated. Regarding discrepancy of desire between the patient and her partner, the patient should be diagnosed with HSDD only if the discrepancy causes her distress.

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