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2.
Eur J Endocrinol ; 183(5): 529-536, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33071222

RESUMO

Objective: Transgender individuals sometimes report a lack of physical change during hormone treatment, such as alterations in muscle tone or fat distribution. Identifying characteristics of this subgroup could be a step toward individualizing hormone therapy in transgender individuals. Therefore, we study the variation of changes in body composition and characteristics associated with a lack of change. Design and methods: Body composition measures were recorded in 323 transmen and 288 transwomen at every visit from the start of hormone therapy to a maximum of 24 months follow-up. Absence of change was defined as transmen with a decrease in lean body mass or transwomen with a decrease in fat percentage. Results: A lack of change at 24 months was observed in 19 of 94 (20.2%) transmen and in 9 of 96 (9.4%) transwomen. The risk of not achieving change in body composition was related to lower testosterone levels and less suppression of LH in transmen (OR: 0.67, 95% CI: 0.48-0.94 per SD increase in testosterone and OR: 1.36, 95% CI: 1.01-1.83 per SD increase in LH). Conclusions: There is a large variation in body composition changes during hormone therapy, with a substantial proportion of individuals with no measurable effects. In transmen, serum testosterone and LH were associated with a lack of change, but serum hormone levels were not associated with body composition changes in transwomen. The results provide a rationale for individualizing hormone therapy in transmen, by considering individual effects rather than solely relying on a standardized dosage of hormone therapy.


Assuntos
Antagonistas de Androgênios/uso terapêutico , Androgênios/uso terapêutico , Composição Corporal , Estradiol/uso terapêutico , Estrogênios/uso terapêutico , Testosterona/uso terapêutico , Pessoas Transgênero , Adulto , Distribuição da Gordura Corporal , Acetato de Ciproterona/uso terapêutico , Relação Dose-Resposta a Droga , Impedância Elétrica , Estradiol/sangue , Feminino , Humanos , Hormônio Luteinizante/sangue , Masculino , Medicina de Precisão , Procedimentos de Readequação Sexual/métodos , Testosterona/análogos & derivados , Testosterona/sangue , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
3.
Eur J Endocrinol ; 183(6): R167-R183, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33105105

RESUMO

Overt hypogonadism in men adversely affects body composition and metabolic health, which generally improve upon testosterone (TS) therapy. As obese men often display lower serum TS levels, in particular when they present with the metabolic syndrome (MetS) or type 2 diabetes (T2DM), there have been claims that androgen therapy prevents or reverses obesity and improves metabolic health. This has contributed to the increase in TS prescriptions during the past two decades. In this narrative review, based on findings from larger observational studies and randomized controlled intervention trials, we evaluate whether low TS predicts or predisposes to obesity and its metabolic consequences, and whether obese men with low TS are truly hypogonadal. We further describe the mechanisms underlying the bi-directional relationships of TS levels with obesity and metabolic health, and finally assess the evidence for TS therapy in men with obesity, MetS and/or T2DM, considering efficacy, safety concerns and possible alternative approaches. It is concluded that low serum sex hormone-binding globulin and total TS levels are highly prevalent in obese men, but that only those with low free TS levels and signs or symptoms of hypogonadism should be considered androgen deficient. These alterations are reversible upon weight loss. Whether low TS is a biomarker rather than a true risk factor for metabolic disturbances remains unclear. Considering the limited number of sound TS therapy trials have shown beneficial effects, the modest amplitude of these effects, and unresolved safety issues, one cannot in the present state-of-the-art advocate TS therapy to prevent or reverse obesity-associated metabolic disturbances. Instead, the focus should remain on lifestyle measures and management of obesity-related consequences.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Terapia de Reposição Hormonal/métodos , Hipogonadismo/tratamento farmacológico , Síndrome Metabólica/tratamento farmacológico , Obesidade/tratamento farmacológico , Testosterona/uso terapêutico , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Humanos , Hipogonadismo/sangue , Hipogonadismo/complicações , Masculino , Síndrome Metabólica/sangue , Síndrome Metabólica/complicações , Obesidade/sangue , Obesidade/complicações , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Globulina de Ligação a Hormônio Sexual/análise , Testosterona/sangue , Resultado do Tratamento
5.
Mayo Clin Proc ; 95(8): 1710-1714, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32753145

RESUMO

Given the rapid spread of the coronavirus disease 2019 (COVID-19) pandemic and its overwhelming effect on health care systems and the global economy, innovative therapeutic strategies are urgently needed. The proposed primary culprit of COVID-19 is the intense inflammatory response-an augmented immune response and cytokine storm-severely damaging the lung tissue and rendering some patients' conditions severe enough to require assisted ventilation. Sex differences in the response to inflammation have been documented and can be attributed, at least in part, to sex steroid hormones. Moreover, age-associated decreases in sex steroid hormones, namely, estrogen and testosterone, may mediate proinflammatory increases in older adults that could increase their risk of COVID-19 adverse outcomes. Sex hormones can mitigate the inflammation response and might provide promising therapeutic potential for patients with COVID-19. In this article, we explore the possible anti-inflammatory effects of estrogen and testosterone and the anabolic effect of testosterone, with particular attention to the potential therapeutic role of hormone replacement therapy in older men and women with COVID-19.


Assuntos
Betacoronavirus , Infecções por Coronavirus/fisiopatologia , Estrogênios/fisiologia , Pneumonia Viral/fisiopatologia , Testosterona/fisiologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Estrogênios/uso terapêutico , Feminino , Terapia de Reposição Hormonal , Humanos , Inflamação/tratamento farmacológico , Inflamação/fisiopatologia , Inflamação/virologia , Masculino , Pandemias , Pneumonia Viral/tratamento farmacológico , Testosterona/uso terapêutico
6.
Am J Psychiatry ; 177(10): 965-973, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-32660299

RESUMO

OBJECTIVE: Low-dose testosterone has been shown to improve depression symptom severity, fatigue, and sexual function in small studies in women not formally diagnosed with major depressive disorder. The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depression symptom severity, fatigue, and sexual function in women with antidepressant-resistant major depression. A functional MRI (fMRI) substudy examined effects on activity in the anterior cingulate cortex (ACC), a brain region important in mood regulation. METHODS: The authors conducted an 8-week randomized double-blind placebo-controlled trial of adjunctive testosterone cream in 101 women, ages 21-70, with antidepressant-resistant major depression. The primary outcome measure was depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints included fatigue, sexual function, and safety measures. The primary outcome of the fMRI substudy (N=20) was change in ACC activity. RESULTS: The participants' mean age was 47 years (SD=14) and their mean baseline MADRS score was 26.6 (SD=5.9). Eighty-seven (86%) participants completed 8 weeks of treatment. MADRS scores decreased in both study arms from baseline to week 8 (testosterone arm: from 26.8 [SD=6.3] to 15.3 [SD=9.6]; placebo arm: from 26.3 [SD=5.4] to 14.4 [SD=9.3]), with no significant difference between groups. Improvement in fatigue and sexual function did not differ between groups, nor did side effects. fMRI results showed a relationship between ACC activation and androgen levels before treatment but no difference in ACC activation with testosterone compared with placebo. CONCLUSIONS: Adjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction. Imaging in a subset of participants demonstrated that testosterone did not result in greater activation of the ACC.


Assuntos
Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Testosterona/uso terapêutico , Adulto , Idoso , Transtorno Depressivo Maior/diagnóstico por imagem , Transtorno Depressivo Resistente a Tratamento/diagnóstico por imagem , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Neuroimagem Funcional , Giro do Cíngulo/diagnóstico por imagem , Humanos , Hidrocortisona/sangue , Imagem por Ressonância Magnética , Pessoa de Meia-Idade , Creme para a Pele , Testosterona/administração & dosagem , Testosterona/sangue , Adulto Jovem
8.
Adv Gerontol ; 33(2): 385-390, 2020.
Artigo em Russo | MEDLINE | ID: mdl-32593257

RESUMO

There are changes in the metabolism, reproductive and nervous systems with ageing, which have a systemic and interrelated nature. The purpose of this work was to demonstrate the effectiveness of audiovisual correction and therapy with testosterone drugs in addition to the standard therapy in patients with polymorbid pathology. 89 men aged 35-55 years old with diabetes mellitus, polymorbid cardiovascular disease, obesity, anxiety and depressive disorders were examined. They were divided into 3 groups depending on the treatment: the 1st - standard therapy and escitalopram / tofisopam; the 2nd - standard therapy + audiovisual correction; the 3rd - standard therapy + audiovisual correction + testosterone undecanoate. Laboratory examination was carried out in all patients before the start of treatment and 9 months after the treatment. The severity of androgen deficiency was determined using IIEF-5 questionnaire and the AMS male aging scale. In was shown a decrease in testosterone levels, signs of erectile dysfunction and symptoms of moderate to severe androgen deficiency, increased proatherogenic and decreased antiatherogenic lipoproteins, increased glucose, glycated hemoglobin, insulin, HOMA index in our study. In group of audiovisual correction we saw a more significant improvement in the lipid profile after treatment. Audiovisual correction and androgen therapy contributed to the improvement of erectile function indices and a decrease in the severity of the symptoms of ageing in men.


Assuntos
Senilidade Prematura/prevenção & controle , Androgênios/uso terapêutico , Recursos Audiovisuais , Terapia de Reposição Hormonal , Idoso , Androgênios/deficiência , Androgênios/farmacologia , Disfunção Erétil/terapia , Humanos , Masculino , Ereção Peniana/efeitos dos fármacos , Testosterona/análogos & derivados , Testosterona/farmacologia , Testosterona/uso terapêutico
9.
Internist (Berl) ; 61(6): 549-557, 2020 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-32377774

RESUMO

Testosterone is a natural hormone which is essential to maintaining physical and emotional wellbeing in men, regardless of age. Male hypogonadism is an endocrine condition of testosterone deficiency with the potential to cause multiple morbidities and psychosocial problems. The condition can be of primary (testicular), secondary (hypothalamic-pituitary) or so-called functional origin (as a result of inflammatory conditions, obesity or chronic illness). Testosterone deficiency can cause symptoms of a sexual nature, foster metabolic dysfunction and impair physical abilities as well as cause osteopenia/osteoporosis and anemia. Testosterone replacement therapy should not be initiated in the case of desired paternity, unclear processes of the prostate or mammary gland and high hematocrit. Diagnosis and treatment as well as monitoring of hypogonadism treatment are clearly regulated by international guidelines and replacement therapy is proven to be effective in ameliorating the above-mentioned symptoms when performed according to these guidelines. In functional hypogonadism, which is most often, but not exclusively, found in older men, treatment of the underlying condition/co-morbidity is mandatory prior to starting testosterone substitution.


Assuntos
Androgênios/uso terapêutico , Terapia de Reposição Hormonal , Hipogonadismo/tratamento farmacológico , Osteoporose/prevenção & controle , Testosterona/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Androgênios/administração & dosagem , Disfunção Erétil/etiologia , Humanos , Hipogonadismo/diagnóstico , Hipogonadismo/etiologia , Masculino , Obesidade , Osteoporose/etiologia , Testosterona/administração & dosagem , Testosterona/efeitos adversos
11.
NeuroRehabilitation ; 46(3): 355-368, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32250330

RESUMO

BACKGROUND: Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function. OBJECTIVE: Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation. DESIGN: Randomized, double blind, placebo-controlled pilot trial. SETTING: Inpatient rehabilitation brain injury unit. PARTICIPANTS: Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation. INTERVENTIONS: Transdermal T gel or placebo. MAIN OUTCOME MEASURES: Revised FIM™ score, strength, adverse events. RESULTS: Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group. CONCLUSIONS: Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.


Assuntos
Androgênios , Lesões Encefálicas Traumáticas , Eunuquismo , Testosterona , Adolescente , Adulto , Idoso , Androgênios/administração & dosagem , Androgênios/efeitos adversos , Androgênios/uso terapêutico , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/fisiopatologia , Lesões Encefálicas Traumáticas/reabilitação , Método Duplo-Cego , Eunuquismo/tratamento farmacológico , Eunuquismo/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Testosterona/administração & dosagem , Testosterona/efeitos adversos , Testosterona/uso terapêutico , Adulto Jovem
12.
J Spec Oper Med ; 20(1): 94-100, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32203613

RESUMO

OBJECTIVE: Due to physical demands, Special Operations Forces (SOF) endure changes in body composition, work capacity, and endocrine function. These changes result in energy deficits and sleep deprivation, where sleep averaged 3 hours/ day, independently known to decrease testosterone levels. The use of exogenous testosterone shows increases in lean body mass (LBM) and muscle function in healthy males and reverses cachexia in diseased populations. Therefore, the review's primary purpose is to summarize and contrast literature in both SOF and nonmilitary personnel regarding the correlation between negative energy balance, sleep deprivation, and decreased testosterone. The secondary purpose summarizes the effects of exogenous testosterone therapy in healthy males as well as reversing the effects of muscle wasting diseases. METHODS: An online literary search from 1975 to 2015 identified 46 of 71 sources addressing both purposes, and data were summarized into tables providing mean observations. CONCLUSIONS: SOF training results in decreased testosterone (-6.3%), LBM (-4.6%), and strength (-11.7%), tied to energy deficits (-3,351 kcal/day) and sleep deprivation (3 hours/ day). Exogenous testosterone therapy increases LBM (6.2%), strength (7.9-14.8%), reverses cachexia (2.0%) and increases strength (12.7%) in those with chronic diseases. Therefore, testosterone supplementation in SOF may attenuate changes in body composition and muscle function during training and sustained Special Operations (SUSOPS).


Assuntos
Composição Corporal , Militares/educação , Força Muscular , Testosterona/metabolismo , Humanos , Masculino , Testosterona/uso terapêutico
14.
Rev. Hosp. Ital. B. Aires (2004) ; 40(1): 34-38, mar. 2020. tab
Artigo em Espanhol | LILACS | ID: biblio-1102292

RESUMO

Las mujeres han sido tratadas por décadas con testosterona intentando aliviar una gran variedad de síntomas con riesgos y beneficios inciertos. En la mayoría de los países, la testosterona se prescribe "off-label", de modo que las mujeres están utilizando compuestos y dosis ideadas para tratamientos en hombres. En este sentido, varias sociedades médicas de distintos continentes adoptaron recientemente por consenso una toma de posición sobre los beneficios y potenciales riesgos de la terapia con testosterona en la mujer, explorar las áreas de incertidumbre e identificar prácticas de prescripción con potencial de causar daño. Las recomendaciones con respecto a los beneficios y riesgos de la terapia con testosterona se basan en los resultados de ensayos clínicos controlados con placebo de al menos 12 semanas de duración. A continuación se comentan las recomendaciones. (AU)


There are currently no clear established indications for testosterone replacement therapy for women. Nonetheless, clinicians have been treating women with testosterone to alleviate a variety of symptoms for decades with uncertainty regarding its benefits and risks. In most countries, testosterone therapy is prescribed off-label, which means that women are using testosterone formulations or compounds approved for men with a modified dose for women. Due to these issues, there was a need for a global Consensus Position Statement on testosterone therapy for women based on the available evidence from placebo randomized controlled trials (RCTs). This Position Statement was developed to inform health care professionals about the benefits and potential risks of testosterone therapy intended for women. The aim of the Consensus was to provide clear guidance as to which women might benefit from testosterone therapy; to identify symptoms, signs, and certain conditions for which the evidence does not support the prescription of testosterone; to explore areas of uncertainty, and to identify any prescribing practices that have the potential to cause harm. (AU)


Assuntos
Humanos , Feminino , Idoso , Testosterona/uso terapêutico , Pós-Menopausa/efeitos dos fármacos , Depressores do Apetite/efeitos adversos , Fenitoína/efeitos adversos , Placebos/administração & dosagem , Psicotrópicos/efeitos adversos , Tamoxifeno/efeitos adversos , Testosterona/administração & dosagem , Testosterona/análise , Testosterona/efeitos adversos , Testosterona/farmacologia , Fármacos Cardiovasculares/efeitos adversos , Indometacina/efeitos adversos , Hormônio Liberador de Gonadotropina/efeitos adversos , Pós-Menopausa/fisiologia , Ensaios Clínicos Controlados como Assunto , Antagonistas Colinérgicos/efeitos adversos , Anticoncepcionais Orais/efeitos adversos , Disfunções Sexuais Psicogênicas/etiologia , Disfunções Sexuais Psicogênicas/terapia , Danazol/efeitos adversos , Consenso , Inibidores da Aromatase/efeitos adversos , Uso Off-Label , Inibidores do Fator Xa/efeitos adversos , Anfetaminas/efeitos adversos , Antagonistas dos Receptores Histamínicos/efeitos adversos , Antagonistas de Androgênios/efeitos adversos , Androgênios/fisiologia , Cetoconazol/efeitos adversos , Entorpecentes/efeitos adversos
15.
Eur J Endocrinol ; 182(6): 539-548, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32213659

RESUMO

Background: Hypogonadism is prevalent during opioid treatment, but the effect of testosterone replacement treatment (TRT) on body composition, pain perception, and adrenal function is unclear. Purpose: To measure changes in body composition, pain perception, quality of life, and adrenal function after TRT or placebo in opioid-treated men with chronic non-malignant pain. Methods: Double-blind, placebo-controlled study in 41 men (>18 years) with total testosterone <12 nmol/L were randomized to 24 weeks TRT (Testosterone undecanoate injection three times/6 months, n = 20) or placebo (placebo-injections, n = 21). Outcomes: Body composition (lean body mass and fat mass assessed by DXA), clinical pain intensity (numerical rating scale), and experimental pain perception (quantitative sensory assessment), quality of life (SF36), and adrenocorticotrophic hormone (ACTH) test. Data were presented as median (quartiles). Mann-Whitney tests were performed on delta values (24-0 weeks) between TRT and placebo. Results: The median age was 55 years (46; 59) and total testosterone before intervention was 6.8 (5.0; 9.3) nmol/L. TRT was associated with change of testosterone levels: 12.3 (7.0; 19.9) nmol/L (P < 0.001 vs placebo), increased lean body mass: 3.6 (2.3; 5.0) kg vs 0.1 kg (-2.1; 1.5) during TRT vs placebo and decreased total fat mass: -1.2 (-3.1; 0.7) kg vs 1.2 kg (-0.9; 2.5) kg, both P < 0.003. Changed pain perception, SF36, and ACTH-stimulated cortisol levels were non-significantly changed during TRT compared with placebo. Conclusions: Six months of TRT improved body composition in men with opioid-induced hypogonadism without significant changes in outcomes of pain perception, quality of life, or adrenal function.


Assuntos
Analgésicos Opioides/efeitos adversos , Terapia de Reposição Hormonal/métodos , Hipogonadismo/induzido quimicamente , Hipogonadismo/tratamento farmacológico , Testosterona/uso terapêutico , Idoso , Composição Corporal/efeitos dos fármacos , Método Duplo-Cego , Humanos , Hipogonadismo/psicologia , Masculino , Pessoa de Meia-Idade , Percepção da Dor/efeitos dos fármacos , Qualidade de Vida , Resultado do Tratamento
16.
Transfusion ; 60(5): 947-954, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32176332

RESUMO

BACKGROUND: Blood donors receiving testosterone replacement therapy (TRT) often require therapeutic phlebotomy due to erythrocytosis. Red blood cells (RBCs) donated by eligible TRT donors are approved for collection and transfusion. This study was aimed at defining the prevalence and demographic determinants of TRT donors at a large USA blood service organization. STUDY DESIGN: Donation data from TRT donors and matched controls was collected from a de-identified electronic donor database across 16 blood centers in 2017-2018. Demographic determinants included race, sex, age, hemoglobin (Hb), body mass index (BMI), mean arterial pressure (MAP), and the frequency of donations in the 2-year period. RESULTS: TRT donors comprised 1.6% of the donor population and produced 2.2% of RBC units during 2018. TRT donors were likely to be middle-aged white or Hispanic men, with high prevalence of obesity (50.8% of TRT donors had BMI ≥30 kg/m2 compared with 36.2% in controls) and intensive donation frequency (1 to 29 donations in 2 years vs. 1 to 12 in controls). TRT donors had significantly (p < 0.0001) higher MAP and Hb compared with controls (MAP 99.9 ± 9.81 vs. 96.5 ± 10.1 mmHg; Hb 17.8 ± 1.44 vs. 15.6 ± 1.37 g/dL). One year of donations was associated with significant decreases in MAP and Hb for TRT donors. CONCLUSIONS: TRT is associated with high prevalence of erythrocytosis and obesity that may explain the intensive donation frequency, high MAP, and Hb. Frequent phlebotomies had a moderately positive effect on blood pressure and Hb levels. Potential implications of TRT on the quality of the RBC products require further evaluation.


Assuntos
Doadores de Sangue/estatística & dados numéricos , Terapia de Reposição Hormonal/estatística & dados numéricos , Testosterona/uso terapêutico , Adulto , Idoso , Bancos de Sangue/organização & administração , Bancos de Sangue/estatística & dados numéricos , Doadores de Sangue/provisão & distribução , Estudos de Casos e Controles , Feminino , Humanos , Hipogonadismo/sangue , Hipogonadismo/tratamento farmacológico , Hipogonadismo/epidemiologia , Masculino , Pessoa de Meia-Idade , Obesidade/sangue , Obesidade/epidemiologia , Policitemia/sangue , Policitemia/epidemiologia , Prevalência , Fatores Socioeconômicos , Estados Unidos/epidemiologia
17.
Eur J Endocrinol ; 182(4): 423-428, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32061160

RESUMO

Objectives: Male hypogonadism is associated with higher risk of co-morbidity and premature mortality. It is, therefore, of utmost importance to identify young men who are at the highest risk of testosterone deficiency and who may benefit from preventive measures. In this context, infertile men constitute a high-risk group. The extent of testosterone replacement therapy (TRT) among infertile men, defined as men who have to undergo assisted reproduction for fatherhood, is currently unknown. Therefore, we evaluated the pattern of prescription of TRT in the years following child conception among men who have fathered children with the help of intracytoplasmic sperm injection (ICSI) or in vitro fertilization (IVF). Design: By sourcing data from national population registries, hazard ratio (HR) for subsequent TRT was assessed for IVF and ICSI-treated men and compared to those who conceived spontaneously with age Cox regression analysis adjusted for age, educational level and previous intake of medicines for metabolic diseases. Results: ICSI and IVF fathers had increased incidence of newly prescribed TRT compared to fathers conceiving spontaneously (ICSI: HR = 3.81, 95% CI = 3.09-4.69, P < 0.001; IVF: HR = 1.54, 95% CI = 1.15-2.05, P = 0.003). After adjustment for prescription of medication for one or more components of the MetS prior to TRT, the risk estimates attenuated but remained robust both for ICSI-treated (HR = 3.17 (95% CI: 2.56-3.9) and IVF-treated men (HR = 1.06 (95% CI: 1.05-1.07). Conclusion: Men who have to utilise powerful techniques, such as ICSI for fathering children, may be at risk for testosterone deficiency. Routine endocrine evaluation of men seeking fertility treatment is hence warranted.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Terapia de Reposição Hormonal/estatística & dados numéricos , Infertilidade Masculina/terapia , Injeções de Esperma Intracitoplásmicas/estatística & dados numéricos , Testosterona/uso terapêutico , Adulto , Fertilização In Vitro/estatística & dados numéricos , Humanos , Infertilidade Masculina/etiologia , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Sistema de Registros , Suécia , Testosterona/deficiência
18.
J Sex Med ; 17(4): 585-594, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32063470

RESUMO

INTRODUCTION: Testosterone has been studied for its benefits on sexual health for decades. The research regarding testosterone in women has produced evidence that this is a potential treatment for women suffering from female sexual dysfunction. There are several limitations of the testosterone trials that can affect their interpretation and challenges posed by some regulatory agencies that have prevented approval of any testosterone treatment for women in several countries. AIM: To summarize the challenges of testosterone trials in terms of study populations, patient-reported outcomes, validated instruments in research, confounders, and regulatory barriers. METHODS: A thorough review of published data on testosterone for the treatment of women's sexual health problems was undertaken. A detailed evaluation of the limitations of these trials was conducted and incorporated with the published evidence on the regulatory processes involved in moving testosterone from clinical research to drug approval. MAIN OUTCOME MEASURE: Main outcome measures are assessment of clinical trial populations, survey tools, confounders, and regulatory barriers. RESULTS: There is some heterogeneity of study populations included in testosterone trials in women. Similarly, there have been differences in instruments used to assess patient-reported outcomes and often minimal control for potential confounders. The regulatory agency had posed a challenge to approve any testosterone treatment for women based on unproven concerns and a lack of regulatory guidance for drug developers. CLINICAL IMPLICATIONS: There is strong evidence that shows testosterone is effective for treating sexual health concerns in the women included in clinical trials. STRENGTH & LIMITATIONS: Strengths include thorough review of published literature and trial design for sexual health concerns. Limitations include being restricted to English Language publications and not having access to unpublished clinical trial data. CONCLUSIONS: Testosterone trials in women have been limited by homogeneity in the study populations and outcomes measured. Drug development has been hampered by inconsistent regulatory barriers. Rowen TS, Davis SR, Parish S, et al. Methodological Challenges in Studying Testosterone Therapies for Hypoactive Sexual Desire Disorder in Women. J Sex Med 2020;17:585-594.


Assuntos
Libido/efeitos dos fármacos , Disfunções Sexuais Psicogênicas/tratamento farmacológico , Testosterona/uso terapêutico , Aprovação de Drogas , Feminino , Humanos , Avaliação de Resultados em Cuidados de Saúde , Saúde Sexual
20.
Am J Obstet Gynecol ; 223(2): 229.e1-229.e8, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32044312

RESUMO

BACKGROUND: An estimated 1.4 million persons in the United States identify as transgender or nonbinary, signifying that their gender identity does not correspond with their assigned sex at birth. Individuals assigned female at birth may seek gender-affirming hormone therapy with testosterone. No studies have directly examined ovulatory function in transmasculine individuals using injectable testosterone. OBJECTIVES: Our primary objective was to determine the effect of testosterone on ovulatory suppression in transmasculine individuals. Secondary objectives were to determine predictors of ovulation in transmasculine individuals on testosterone, and to assess the effect of testosterone on antimüllerian hormone. MATERIALS AND METHODS: This prospective observational study recruited participants from a community clinic that provides gender-affirming hormone therapy. Enrolled individuals were assigned female at birth and were currently using or seeking to initiate masculinizing therapy with injectable testosterone esters (transmasculine individuals). Over a 12-week study period, participants collected daily urine samples for pregnanediol-3-glucoronide testing and completed daily electronic bleeding diaries. We assessed monthly serum mid-dosing interval testosterone, estradiol and sex hormone binding globulin, and antimüllerian hormone values at baseline and study end. Ovulation was defined as pregnanediol-3-glucoronide greater than 5 µg/mL for 3 consecutive days. The primary outcome was the proportion of participants who ovulated during the study period. We examined predictors of ovulation such as age, length of time on testosterone, serum testosterone levels, body mass index, and bleeding pattern. RESULTS: From July to November 2018, we enrolled 32 individuals; 20 completed the study (14 continuing testosterone users, 6 new users). Median age was 23 years (range 18-37 years). Bleeding or spotting during the study period was noted by 41% of participants (13/32). Among continuing users, median testosterone therapy duration was 11 months (range 1-60 months). A single ovulation was observed out of a total of 61 combined months of testosterone use; however, several transient rises in pregnanediol-3-glucoronide followed by bleeding episodes were suggestive of 7 dysfunctional ovulatory cycles among 7 individuals. There was no difference in antimüllerian hormone from baseline to 12 weeks between participants initiating testosterone and continuing users of testosterone. We did not have the power to examine our intended predictors given the low numbers of ovulatory events, but found that longer time on testosterone and presence of vaginal bleeding over 12 weeks were associated with transient rises in pregnanediol-3-glucoronide. CONCLUSION: This study suggests that testosterone rapidly induces hypothalamic-pituitary-gonadal suppression, resulting in anovulation in a proportion of new users. Importantly, these data also suggest that some long-term testosterone users break through the hormonal suppression and experience an ovulatory event, thereby raising concerns pertaining to the need for contraception in transmasculine individuals engaged in sexual intercourse with sperm-producing partners. Given the small number of overall participants, this work is hypothesis generating. Larger studies are needed to confirm and to clarify these findings.


Assuntos
Androgênios/uso terapêutico , Hormônio Antimülleriano/sangue , Disforia de Gênero/tratamento farmacológico , Inibição da Ovulação , Ovulação/urina , Pregnanodiol/análogos & derivados , Procedimentos de Readequação Sexual , Testosterona/uso terapêutico , Pessoas Transgênero , Adolescente , Adulto , Feminino , Humanos , Masculino , Menstruação , Pregnanodiol/urina , Resultado do Tratamento , Adulto Jovem
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