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Kacker R.,Mens Health Boston | Conners W.,Mens Health Boston | Zade J.,Mens Health Boston | Zade J.,New York Medical College | Morgentaler A.,Mens Health Boston
Journal of Urology | Year: 2014

Purpose Testosterone deficiency is a known risk factor for osteopenia and osteoporosis in older men. Less is known about the impact of testosterone deficiency on bone mineral density in younger men. Materials and Methods We retrospectively reviewed the charts at an andrology/infertility clinic and identified 399 men younger than 50 years who underwent baseline dual energy x-ray absorptiometry and had total testosterone less than 350 ng/dl or free testosterone less than 1.5 ng/dl. Additional analysis was done in a subgroup of 75 men (18.8%) in whom dual energy x-ray absorptiometry was repeated after treatment at a mean ± SD of 30.4 ± 16.2 months. The determination of osteoporosis or osteopenia was based on T-scores (osteopenia less than -1.0 and osteoporosis less than -2.5) of the lumbar spine and left hip. Results Of all 399 men 141 (35.3%) had bone mineral density consistent with osteopenia at the lumbar spine (137) and/or the total hip (19). In 11 men (2.75%) bone mineral density was consistent with osteoporosis at the lumbar spine. On multivariate analysis higher body mass index was independently associated with increased bone mineral density at the spine (p <0.0001) as well as the hip (p <0.001). Testosterone treatment in 43 men increased spine bone mineral density (p <0.001). Significant decreases in spine bone mineral density developed in 21 men treated with clomiphene citrate or anastrazole (p = 0.003). No significant change was noted in hip bone mineral density for any treatment. Conclusions More than a third of men younger than 50 years with testosterone deficiency and infertility or sexual dysfunction had decreased bone mineral density. Testosterone treatment increased bone mineral density while estrogen modulators such as clomiphene citrate or aromatase inhibitors decreased bone mineral density. These results suggest that dual energy x-ray absorptiometry may be warranted in young men with testosterone deficiency. © 2014 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.


Gooren L.,VU University Amsterdam | Morgentaler A.,Mens Health Boston | Morgentaler A.,Beth Israel Deaconess Medical Center
Andrologia | Year: 2014

Summary: Male-to-female transsexual persons (MtoF) undergo treatment with antiandrogens and oestrogens followed by bilateral orchiectomy. The aim of this study was to investigate the incidence of prostate cancer (PCa) in a cohort of MtoF individuals. Medical records 2306 MtoF treated between 1975 and 2006 of the Amsterdam Gender Clinic were reviewed. Mean age at initiation of treatment was 29.3 ± 12.7 years (range 16-83). Mean follow-up was 21.4 years, resulting in a combined total of 51 173 person-years of exposure and follow-up. Follow-up more than 20 years was available for 303 individuals, including follow-up of more than 30 years in 151 individuals. A single case of PCa was identified in this group. The overall incidence of PCa in this population was 0.04% and 0.13% for individuals who had initiated hormonal treatment after at 40 years or later. PCa in this large MtoF population was rare. However, underdiagnosis is likely due to lack of close prostate monitoring and suppression of PSA due to androgen deprivation. In addition, only a limited number of MtoF individuals have yet reached old age when PCa becomes more common. When diagnosed in this population, there appears to be a tendency for PCa to behave aggressively. Prostate monitoring should be considered in these individuals beginning at age 50 years. © 2013 Blackwell Verlag GmbH.


Kacker R.,Mens Health Boston | Hult M.,Mens Health Boston | San Francisco I.,Pontifical Catholic University of Chile | Conners W.,Mens Health Boston | And 3 more authors.
Asian Journal of Andrology | Year: 2016

This report presents our experience with T therapy in a cohort of T-deficient men on active surveillance (AS) for Gleason 3 + 3 and Gleason 3 + 4 prostate cancer (PCa). A retrospective chart review identified 28 men with T deficiency who underwent T therapy (T group) for at least 6 months while on AS for PCa. A comparison group of 96 men on AS for PCa with untreated T deficiency (no-T group) was identified at the same institution. The AS protocol followed a modified Epstein criteria and allowed inclusion of men with a single core of low-volume Gleason 3 + 4 PCa. Mean age was 59.5 and 61.3 years, and mean follow-up was 38.9 and 42.4 months for the T and no-T groups, respectively. Of all 28 men in the T group, 3 (10.7%) men developed an increase in Gleason score while on AS. Of 22 men in the T group with Gleason 3 + 3 disease, 7 (31.8%) men developed biopsy progression including 3 men (13.6%) who developed Gleason 3 + 4 PCa. Of 6 men with Gleason 3 + 4 disease at baseline, 2 (33.3%) men developed an increase in tumor volume, and none developed upgrading beyond Gleason 3 + 4. All 96 men in the no-T group had Gleason 3 + 3 disease at baseline and, 43 (44.7%) developed biopsy progression, including 9 men (9.38%) with upgrading to Gleason 7 (3 + 4). Biopsy progression rates were similar for both groups and historical controls. Biopsy progression in men on AS appears unaffected by T therapy over 3 years. Prospective placebo-controlled trials of T therapy in T-deficient men on AS should be considered given the symptomatic benefits experienced by treated men. © 2016 AJA, SIMM & SJTU. All rights reserved.


Morgentaler A.,Mens Health Boston | Morgentaler A.,Beth Israel Deaconess Medical Center
Urologic Clinics of North America | Year: 2011

With increased recognition of the benefits of testosterone (T) therapy for middle-aged men, there has been a concomitant reexamination of the historical fear that raising T will result in more prostate cancer (PCa). Studies have failed to show increased risk of PCa in men with higher serum T, and supraphysiologic T fails to increase prostate volume or prostate-specific antigen in healthy men. This apparent paradox is explained by the Saturation Model, which posits a finite capacity of androgen to stimulate PCa growth. Modern studies indicate no increased risk of PCa among men with serum T in the therapeutic range. © 2011 Elsevier Inc.


Rosen R.C.,New England Research Institutes, Inc. | Araujo A.B.,New England Research Institutes, Inc. | Connor M.K.,New England Research Institutes, Inc. | Gerstenberger E.P.,New England Research Institutes, Inc. | And 4 more authors.
Clinical Endocrinology | Year: 2011

Objective Hypogonadism (HG) is a clinical disorder consisting of reduced testosterone (T) levels and characteristic signs and symptoms of low T. Current instruments used to assess hypogonadal symptoms in men lack adequate measurement properties. To present data on the quantitative validation of a new self-report instrument (HG Screener) developed to identify men with symptoms of HG. Design This is a psychometric validation study conducted at 16 clinical sites across the Unites States. Subjects completed two visits separated by 2-4 weeks. Patients One hundred and thirty-one men (82 hypogonadal patients with total T ≤ 10·4 nmol/l and 49 controls with total T > 10·4 nmol/l) aged 21-75 years were enrolled. Measurements Self-reported assessments including the HG Screener (at both visits) along with seven validated questionnaires. Results The results of a factor analysis identified five functional factors or domains. The resulting instrument contains 25 items consisting of 18 functional items in five core domains (sexual function, mood, memory, sleep function and fatigue) and seven physical symptom items. Overall, the new instrument was found to have strong psychometric properties, including acceptable discriminant, construct and content validity, as well as good internal consistency and test-retest reliability. Conclusions A new screening tool (HG Screener) for identifying men with HG has been developed and validated according to FDA standards. This new instrument possesses acceptable psychometrics and is available for clinical or research use. © 2011 Blackwell Publishing Ltd.


Kacker R.,Mens Health Boston | Hornstein A.,University of Massachusetts Medical School | Morgentaler A.,Mens Health Boston
Aging Male | Year: 2013

Introduction: The value of clinically available free testosterone (FT) assays remains controversial. Here, we evaluate the agreement between the radioimmunoassay (RIA) and calculated FT (cFT) versus equilibrium dialysis (EqD), considered the gold standard. Methods: Fifty-six consecutive men (aged 26-77) had blood samples assessed for FT, including men with treated and untreated testosterone deficiency (TD) and men without TD. Samples were split and tested by the two methodologies at a Quest Diagnostics national reference laboratory. cFT was calculated by the Vermeulen method. Results: A robust correlation was noted for RIA and EqD (r=0.966) and for cFT and EqD (r=0.986). Strong correlations were observed for men receiving testosterone therapy and for men in the lowest and highest quartiles for total and FT. The correlation of total testosterone with FT was similar for cFT (r=0.843), RIA (r=0.806), and EqD (r=0.809). Sex-hormone binding globulin (SHBG) was not correlated with any measure of FT. Bland-Altman analysis demonstrated similar bias for both cFT and RIA, although cFT consistently overestimated FT. Numerical values for RIA were approximately one seventh of EqD values. Conclusions: These results support the clinical use of both RIA and cFT as measures of FT. Due to numerical differences, each test requires its own set of reference values. © 2013 Informa UK Ltd.


Morgentaler A.,Mens Health Boston | Conners W.P.,Mens Health Boston
Asian Journal of Andrology | Year: 2015

For several decades any diagnosis of prostate cancer (PCa) has been considered an absolute contraindication to the use of testosterone (T) therapy in men. Yet this prohibition against T therapy has undergone recent re-examination with refinement of our understanding of the biology of androgens and PCa, and increased appreciation of the benefits of T therapy. A reassuringly low rate of negative outcomes has been reported with T therapy after radical prostatectomy (RP), radiation treatments, and in men on active surveillance. Although the number of these published reports are few and the total number of treated men is low, these experiences do provide a basis for consideration of T therapy in selected men with PCa. For clinicians considering offering this treatment, we recommend first selecting patients with low grade cancers and undetectable prostate-specific antigen following RP. Further research is required to define the safety of T therapy in men with PCa. However, many patients symptomatic from T deficiency are willing to accept the potential risk of PCa progression or recurrence in return for the opportunity to live a fuller and happier life with T therapy. © 2015 AJA, SIMM & SJTU. All rights reserved.


Aversa A.,University of Rome La Sapienza | Morgentaler A.,Mens Health Boston
Nature Reviews Urology | Year: 2015

Despite increased global interest in testosterone deficiency in men and its treatment with testosterone therapy, practical aspects of care remain confusing to many practitioners. Testosterone deficiency can result from testicular dysfunction (primary hypogonadism) or hypothalamic-pituitary dysfunction (secondary hypogonadism), and be congenital or acquired. Sexual and nonsexual symptoms of testosterone deficiency can negatively affect quality of life and cause considerable general health concerns. Investigation of testosterone deficiency should be undertaken in men with symptoms of reduced libido, erectile dysfunction, depression, fatigue, poor concentration, and poor memory. Total and free testosterone are the most frequently used tests and evaluating serum concentrations of luteinizing hormone AIDS determination of primary versus secondary testosterone deficiency. Multiple formulations of testosterone therapy are available, but symptomatic benefits might not manifest for several weeks to many months; long-acting formulations are convenient and improve compliance. Concerns regarding cardiovascular and prostate cancer risks are not supported by current evidence, monitoring during therapy is mandatory. On balance, testosterone therapy can be considered a safe and effective treatment for testosterone deficiency. © 2015 Macmillan Publishers Limited.


PubMed | Mens Health Boston
Type: Journal Article | Journal: Asian journal of andrology | Year: 2015

This report presents our experience with T therapy in a cohort of T-deficient men on active surveillance (AS) for Gleason 3 + 3 and Gleason 3 + 4 prostate cancer (PCa). A retrospective chart review identified 28 men with T deficiency who underwent T therapy (T group) for at least 6 months while on AS for PCa. A comparison group of 96 men on AS for PCa with untreated T deficiency (no-T group) was identified at the same institution. The AS protocol followed a modified Epstein criteria and allowed inclusion of men with a single core of low-volume Gleason 3 + 4 PCa. Mean age was 59.5 and 61.3 years, and mean follow-up was 38.9 and 42.4 months for the T and no-T groups, respectively. Of all 28 men in the T group, 3 (10.7%) men developed an increase in Gleason score while on AS. Of 22 men in the T group with Gleason 3 + 3 disease, 7 (31.8%) men developed biopsy progression including 3 men (13.6%) who developed Gleason 3 + 4 PCa. Of 6 men with Gleason 3 + 4 disease at baseline, 2 (33.3%) men developed an increase in tumor volume, and none developed upgrading beyond Gleason 3 + 4. All 96 men in the no-T group had Gleason 3 + 3 disease at baseline and, 43 (44.7%) developed biopsy progression, including 9 men (9.38%) with upgrading to Gleason 7 (3 + 4). Biopsy progression rates were similar for both groups and historical controls. Biopsy progression in men on AS appears unaffected by T therapy over 3 years. Prospective placebo-controlled trials of T therapy in T-deficient men on AS should be considered given the symptomatic benefits experienced by treated men.


PubMed | University of Rome La Sapienza and Mens Health Boston
Type: Journal Article | Journal: Nature reviews. Urology | Year: 2015

Despite increased global interest in testosterone deficiency in men and its treatment with testosterone therapy, practical aspects of care remain confusing to many practitioners. Testosterone deficiency can result from testicular dysfunction (primary hypogonadism) or hypothalamic-pituitary dysfunction (secondary hypogonadism), and be congenital or acquired. Sexual and nonsexual symptoms of testosterone deficiency can negatively affect quality of life and cause considerable general health concerns. Investigation of testosterone deficiency should be undertaken in men with symptoms of reduced libido, erectile dysfunction, depression, fatigue, poor concentration, and poor memory. Total and free testosterone are the most frequently used tests and evaluating serum concentrations of luteinizing hormone aids determination of primary versus secondary testosterone deficiency. Multiple formulations of testosterone therapy are available, but symptomatic benefits might not manifest for several weeks to many months; long-acting formulations are convenient and improve compliance. Concerns regarding cardiovascular and prostate cancer risks are not supported by current evidence, monitoring during therapy is mandatory. On balance, testosterone therapy can be considered a safe and effective treatment for testosterone deficiency.

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