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The use of testosterone by women

The use of testosterone by women

NEW ORLEANS — Premenopausal and postmenopausal women reporting a persistent, low libido that profoundly impairs quality of life can experience an improvement in symptoms with transdermal testosterone, but clinicians must consider several important points before prescribing the therapy, according to a speaker at the Androgen Society annual meeting. Among postmenopausal women and women who experienced surgical menopause or premature ovarian failure, studies show that low testosterone levels are closely correlated with reduced coital frequency and loss of sexual desire, and researchers have observed a positive relationship between free testosterone levels and the rating of sexual desire via interview questions, Parish said during her presentation. However, androgen levels in women decline over the age span, and that decline is most marked during the mid- to late 30s and 40s — typically, not correlating with the onset of menopause. Androgenic effects, Parish said, vary according to individual variations in the amount and activity of the enzymes 5-alpha reductase and aromatase, as well as individual differences in androgen-receptor response. A measurement of serum testosterone in women, she said, does not provide a specific measure of androgen tissue exposure or action. Additionally, there is no serum androgen level that defines female androgen insufficiency.

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Testosterone therapy: Is it for women?

There are no clearly established indications for testosterone therapy for women. Nonetheless, clinicians have treated women with testosterone for decades, with the intention of alleviating a variety of symptoms, with uncertain benefits and risks.

In most countries, testosterone therapy is prescribed off-label such that women are using either testosterone formulations approved for men with dose modification, or compounded therapies. This Position Statement was developed, by consensus between the participating organizations, to inform health care professionals of the known benefits and potential risks of testosterone therapy for women.

The aims were to provide clear guidance as to which women might benefit from testosterone therapy, to identify symptoms, signs, and conditions for which evidence does not support the prescribing of testosterone, to explore areas of uncertainty, and to identify any prescribing practices that have the potential to cause harm. A Task Force of representatives of leading societies, whose international memberships include clinicians assessing and managing sex steroid therapy for women, was established.

The Task Force agreed on the issues that needed to be addressed, after which a systematic review and meta-analysis of the benefits and risks of testosterone therapy for women were conducted 1.

The Task Force then met on 17 May in Berlin, Germany, and drafted this consensus position statement. The findings are reported with Levels of evidence and Grades of Recommendations 2. Clinical practice recommendations are agreed expert opinions of the panel. Through constructive discussion, unanimous consensus agreement was reached on all the Expert Opinion recommendations included here.

Testosterone concentrations decline during the reproductive years 3 , 4 Level IIB. Testosterone concentrations appear to be maintained in women beyond the age of 65 years, but whether this confers a benefit is yet to be understood 3 , 5 Level IIB.

Direct assays for the measurement of total and free testosterone are highly unreliable in the female range 6 , 7 Grade A. Traditional specifiers i. Recommendations pertaining to the associations between endogenous androgen concentrations and female sexual function.

The associations between endogenous androgen concentrations and sexual function in women remain uncertain because of issues relating to the sensitivity and specificity of androgen assays in some studies and insufficient data Insufficient.

The physiology of androgens is complex because of their conversion in tissues and possible intracrine metabolism in multiple tissues Insufficient. No cutoff blood level can be used for any measured circulating androgen to differentiate women with and without sexual dysfunction 15 Grade C.

There are insufficient data to make any recommendations regarding the use of testosterone in premenopausal women for treatment of sexual function or any other outcome Insufficient. Because the majority of studies reporting on sexual function recruited women assessed as having HSDD or generalized FSD, these recommendations cannot be generalized to other subtypes of FSD or women without sexual dysfunction Expert Opinion. The recommendations of 4 a do not apply to injectables, pellets, or formulations that result in supraphysiological blood concentrations of testosterone, or compounded preparations Expert Opinion.

Recommendations regarding the effects of testosterone on wellbeing, mood, and cognition in postmenopausal women. There is insufficient evidence to support the use of testosterone to enhance cognitive performance, or to delay cognitive decline, in postmenopausal women Insufficient. Testosterone may improve wellbeing in premenopausal women but data are inconclusive Level 1, Grade B.

Of the studies that have reported musculoskeletal outcomes, the number of included participants has been small, all participants were taking concurrent estrogen therapy, and no studies have been in women with osteoporosis. The available data do not support an effect of testosterone treatment on bone mineral density at the spine, total hip, or femoral neck at 12 months Level I, Grade A.

No statistically significant effect of testosterone administered in physiologic doses has been demonstrated on lean body mass, total body fat, or muscle strength Level I, Grade A. There is a need for clinical trials to evaluate the impact of testosterone treatment on musculoskeletal tissues Expert Opinion. Oral testosterone therapy is associated with adverse lipid profiles with negative effects on high-density lipoprotein-cholesterol and low-density lipoprotein-cholesterol levels, and is not recommended Level I, Grade A.

Studies of nonoral testosterone therapies percutaneous and injectable , in doses that approximate physiological testosterone concentrations for premenopausal women, have shown no statistically significant adverse effects on lipid profiles over the short term Level I, Grade A. Testosterone therapy has not been associated with increases in blood pressure, blood glucose, or HbA1c levels Level I, Grade A. A nonsignificant trend for an increased risk of deep venous thrombosis has been seen with testosterone therapy; however, the role of concurrent estrogen therapy in possible venous thrombosis risk cannot be excluded Level I, Grade A.

Limited data preclude assessment of the effects of testosterone therapy on myocardial infarction or death Insufficient data. RCTs of testosterone therapy have excluded women at high cardiometabolic disease risk; most have included women taking concurrent estrogen therapy, and all have been of relatively short duration. Available data suggest that short-term transdermal testosterone therapy does not impact breast cancer risk Level I, Grade A.

There are no data to support the use of testosterone therapy to prevent breast cancer Insufficient data. Women with a prior diagnosis of breast cancer were excluded from the randomized trials for HSDD. Caution is recommended for testosterone use in women with hormone-sensitive breast cancer Expert Opinion. Testosterone therapy for postmenopausal women, in doses that approximate physiological testosterone concentrations for premenopausal women, is not associated with serious adverse events Level I, Grade A.

Safety data for testosterone in physiologic doses are not available beyond 24 months of treatment Level I, Grade A. Treatments should follow this biopsychosocial model and include pharmacologic options hormone therapies and other pharmacologic agents , psychotherapy, or multimodal treatments that combine both 17 Grade B.

The only evidence-based indication for the use of testosterone in women is for the treatment of postmenopausal women who have been diagnosed as having HSDD after formal biopsychosocial assessment Level I, Grade A.

There is an unmet need for the provision and approval of testosterone treatments specific to women, formulated with the aim of approximating physiological testosterone concentrations for premenopausal women Expert Opinion. Where an appropriate approved female testosterone preparation is not available, off-label, prescribing of an approved male formulation is reasonable, provided hormone concentrations are maintained in the physiologic female range Expert Opinion.

In the absence of an available approved product, if a compounded product is needed, the compounding pharmacy should be compliant with purity of Active Pharmaceutical Ingredients and Good Manufacturing Practice to meet industry standards for quality and safety. Dosing should be limited to achieving testosterone concentrations in the physiologic premenopausal range.

Use of any testosterone preparation that results in supraphysiologic concentrations of testosterone, including pellets and injections, is not recommended Expert Opinion.

Should a trial of testosterone therapy be given for HSDD, a baseline total testosterone concentration should be measured before commencement, with a repeat level 3—6 weeks after treatment initiation Level IIA, Grade C. Patients should be monitored for their clinical response to treatment and assessed for signs of androgen excess with a serum total testosterone level every 6 months, to screen for overuse Expert Opinion. Systemic dehydroepiandrosterone is not associated with significant improvement in libido or sexual function in postmenopausal women with normal adrenal function and cannot be recommended for women with HSDD 18 Level IA, Grade A.

In the absence of vulvovaginal atrophy, vaginal dehydroepiandrosterone has not been tested and thus cannot be recommended for treatment of HSDD Expert Opinion. Recommendations regarding the design of future trials of physiologically dosed testosterone Expert Opinion for all.

More adequately powered, double-blind RCTs, without selection bias and with consistent reporting of standardized outcomes, are needed to comprehensively establish the benefits and risks of testosterone therapy for women. Presently, no questionnaire covers all domains of female sexual function such that a combination of domains from different questionnaires should be used.

Satisfying sexual events should no longer be used as a primary efficacy measurement in clinical trials of women with FSD. There is a need for an instrument to assess sexual function with the following characteristics: general applicability; not disease-specific; high discriminant validity between women diagnosed with FSD and sexually functional women; validated, to measure FSD per se and as an instrument to screen for and diagnose FSD and demonstrating clinically meaningful response to intervention; cover different domains, with each domain comprising several items; translated and back-translated in a variety of languages, satisfies the most stringent assessment to gain approval by regulatory agencies.

There is a need for adequately powered RCTs of the effects of testosterone on cognitive performance. Studies must be undertaken to establish the longer term cardiometabolic and breast safety of testosterone therapy for women.

The international panel concluded the only evidence-based indication for testosterone therapy for women is for the treatment of HSDD, with available data supporting a moderate therapeutic effect. There are insufficient data to support the use of testosterone for the treatment of any other symptom or clinical condition, or for disease prevention. Meta-analyses of the available data show no severe adverse events during physiological testosterone use, with the caveat that women at high cardiometabolic risk were excluded from study populations.

The safety of long-term testosterone therapy has not been established. It was considered of utmost importance that the diagnosis of HSDD involves a full clinical assessment and that other factors contributing to FSD must be identified and addressed before testosterone therapy is initiated 10 , A blood total testosterone level should not be used to diagnose HSDD.

Treatment should only be with formulations that achieve blood concentrations of testosterone that approximate premenopausal physiological concentrations. Because no approved female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly. The panel recommended against the use of compounded testosterone. The panel highlighted the pressing need for more research into testosterone therapy for women and the development and licensing of products indicated specifically for women.

The authors thank Lee Tomkins, Executive Director, International Menopause Society, for her assistance in the planning and coordination of the consensus meeting.

There is no other external funding to report. Disclosure Summary: S. There are no other potential conflicts to declare. Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Efficacy and safety of testosterone therapy for women: a systematic review and meta-analysis of randomized controlled trails. Lancet Diabetes Endocrinol. In press. Developing clinical guidelines. West J Med. Google Scholar. Androgen levels in adult females: changes with age, menopause, and oophorectomy. J Clin Endocrinol Metab. Age-specific reference ranges for serum testosterone and androstenedione concentrations in women measured by liquid chromatography-tandem mass spectrometry.

Determinants of serum total and free testosterone levels in women over the age of 65 years. Measurement of total serum testosterone in adult men: comparison of current laboratory methods versus liquid chromatography-tandem mass spectrometry. Accuracy of first and second generation testosterone assays and improvement through sample extraction.

Clin Chem. Toward excellence in testosterone testing: a consensus statement. Endocr Rev. Mayo Clin Proc. Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions-part III. J Sex Med. Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions-part II. Sexual dysfunctions, in 17 conditions related to sexual health.

Accessed 22 July Circulating androgen levels and self-reported sexual function in women. Efficacy and safety of transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder: a systematic review and meta-analysis.

Fertil Steril. Female sexual dysfunction-medical and psychological treatments, committee 14 published correction appears in J Sex Med.

Testosterone and Women

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There are no clearly established indications for testosterone therapy for women. Nonetheless, clinicians have treated women with testosterone for decades, with the intention of alleviating a variety of symptoms, with uncertain benefits and risks.

The lack of availability of testosterone for postmenopausal women in the UK is morally wrong, an expert has said. The criticism comes after a taskforce brought together by the International Menopause Society IMS found testosterone could help women with hypoactive sexual desire dysfunction HSDD , asignificantly reduced interest in sex after menopause. It confirms postmenopausal women with HSDD can benefit from improved sexual desire, arousal, orgasm and pleasure, as well as reduced distress about sex. The statement points out that the evidence does not support the use of testosterone for any other symptoms or medical condition.

Important Announcement

Not applicable since all data that are referred to in this article will have been obtained through reading original studies or contacting the authors of cited studies. Testosterone therapy for women is in widespread use, primarily in the form of compounded preparations and off-label use of formulations for men. The benefits and risks of such therapy remain uncertain. This review will identify and evaluate studies that have examined the effects of testosterone therapy for women on a range of outcomes including sexual function, cardiovascular events, metabolic parameters, musculoskeletal health, wellbeing, cancer events, androgenic effects and withdrawal rates. Assessing a range of outcomes, we will assess the risk-of-bias of relevant studies and draw conclusions about the strength of evidence for benefits and risks of testosterone therapy for each outcome. This comprehensive systematic review with meta-analysis will provide the foundation for the development of evidence-based clinical practice guidelines that will address benefits and risks of testosterone therapy, when treatment might be appropriate or inappropriate, areas of clinical uncertainty and the basis for assessment and monitoring of patients. Testosterone has important physiological roles in female reproductive and non-reproductive health. There is a physiological decline in testosterone with age that commences prior to natural menopause [ 2 — 4 ]. The greatest decline in circulating testosterone occurs during the late reproductive years [ 2 ].

Testosterone improves libido, quality of life in women with low sexual desire

Currently, no androgen therapies are FDA approved for the treatment of female sexual dysfunction. FDA-approved testosterone patches are approved for the treatment of male hypogonadism, but use of these patches in women is not recommended since they would result in very high circulating testosterone levels. Testosterone subcutaneous implants, pellets, and intramuscular injections also are not recommended for women because of the risk of excessive dosing. Small trials of menopausal women taking oral estrogen with low sexual desire found that oral formulations of testosterone improved libido in this study population.

For now, we are minimizing lab research activity to the extent possible. Androgen deficiency in women is a topic that the medical community has been slow to address.

Some try testosterone to boost a sagging libido, but this therapy is still unproven in women. You've probably seen those TV ads targeted to men with "low T," a drop in testosterone level that often occurs with age. Because this male hormone is an instrumental component in sexual desire, declining libido is a common symptom of "low T. Women's bodies also produce testosterone.

Testosterone therapy in women: a review

Although, few preparations designed to deliver an appropriate dose of testosterone for women are available, use of testosterone by women for the management of low libido is widespread. Issues that continue to simulate debate regarding the use of testosterone therapy for women include whether HSDD is a condition that merits pharmacotherapy, how effective is such treatment and whether testosterone therapy is safe. Circulating levels of testosterone and the major adrenal pre-androgens, dehydroepiandrosterone DHEA , DHEA sulphate DHEAS and androstenedione decline with age in women, with the maximal rate of decline occurring in the premenopausal years [1].

Research shows that the hormone testosterone may improve sexual function in specific groups of women, but data on safety and effectiveness are limited. The long-term safety of testosterone therapy for women also is unknown. Given the limited research on effectiveness and safety and the number of potential serious side effects, testosterone isn't a common treatment for sexual dysfunction. Long-term safety data on testosterone therapy for postmenopausal women who have a history of breast or uterine cancer or those who have cardiovascular or liver disease is lacking. Testosterone therapy comes in many forms, such as creams, gels, patches or pills. The method of administration and dose relate to safety risks, so it's important to discuss pros and cons with your doctor.

Therapeutic use of testosterone for women

Androgens are hormones produced by the ovaries and adrenal glands, with the principal androgen being testosterone. In women, the ovaries directly release testosterone into the blood stream, but testosterone can also be made from other hormones that come from the ovaries and adrenal glands such as DHEA and androstenedione. In women and men, testosterone acts directly in cells, but it is also converted to estrogen, and has vital biological effects through estrogen action. Testosterone blood levels in men are about fold greater than in women and result in the male features we tend to associate with testosterone, such as deeper voice, more body hair, more muscle and so forth. Testosterone blood levels in women tend to peak during their 20s. This is followed by a gradual decline with age. By the time a woman reaches menopause, blood testosterone levels are about one quarter of what they were at their peak.

Jun 19, - Testosterone preparations are not approved by the Food and Drug Administration for use in women. So if testosterone is prescribed, it's for.

Вы можете читать все, что пожелаете, - без всяких вопросов и запросов. Вы выиграли. - Почему бы не сказать - мы выиграли. Насколько мне известно, ты сотрудник АНБ. - Ненадолго, - буркнул Хейл.

Calls for testosterone to be licensed in UK for postmenopausal women

Клубы. Для панков? - переспросил бармен, странно посмотрев на Беккера. - Да. Есть ли в Севилье такое место, где тусуются панки.

Low sexual desire: Appropriate use of testosterone in menopausal women

ГЛАВА 11 Испания. Я отправил Дэвида в Испанию. Слова коммандера словно обожгли Сьюзан.

Сьюзан отдала приказ: - Перепечатайте сверху .

Время идет, старик канадец может куда-нибудь исчезнуть. Вполне вероятно, он решит поскорее вернуться в Канаду. Или надумает продать кольцо. Беккер не мог ждать.

Он решительно поднял трубку, снова набрал номер и прислонился к стене.

Effects of testosterone therapy for women: a systematic review and meta-analysis protocol

На другой стороне авениды Изабеллы он сразу же увидел клинику с изображенным на крыше обычным красным крестом на белом поле. С того момента как полицейский доставил сюда канадца, прошло уже несколько часов. Перелом запястья, разбитая голова - скорее всего ему оказали помощь и давно выписали. Беккер все же надеялся, что в клинике осталась какая-то регистрационная запись - название гостиницы, где остановился пациент, номер телефона, по которому его можно найти.

Если повезет, он разыщет канадца, получит кольцо и тут же вернется домой.

- Я не могу выйти за тебя замуж.  - Она отвернулась. Ее плечи подрагивали.

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  1. Akinolar

    Rather valuable idea