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Morgentaler A.,Mens Health Boston | McGettigan J.,A-Life Medical | Xiang Q.,Endo Pharmaceuticals | Danoff T.M.,Endo Pharmaceuticals | Gould E.M.,Endo Pharmaceuticals
International Journal of Impotence Research | Year: 2014

The objective of this study was to assess drying time after application of testosterone 2% gel (Fortesta Gel, Endo Pharmaceuticals), time needed for serum total testosterone (TT) to reach the eugonadal range (≥300 ng dl-1), and time to steady-state serum TT. Thirty-four men with primary or secondary hypogonadism were enrolled in the study; 31 men were included in the pharmacokinetics (PKs) population. Testosterone 2% gel (40 mg) was applied once daily in the morning to the front and inner thighs for 14 days. Median gel drying time was 2.4 min (95% confidence interval (CI), 1.7-3.4 min; n=31). Serum TT concentrations reached the target eugonadal range with a median time of 2.9 h (95% CI, 1.9-4.3 h; n=24). Median time to steady-state serum TT concentration was 1.1 days (95% CI, 0.7-3.4 days; n=31). Six patients (17.6%; n=34) reported treatment-related adverse events; all were mild. The results from this 14-day PK study in men with hypogonadism suggest that testosterone 2% gel dries, on average, in <3 min after application and that testosterone 2% gel rapidly reaches the target eugonadal range and attains steady-state serum TT concentrations in about 1 day. © 2014 Macmillan Publishers Limited All rights reserved. Source

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. Source

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. Source

Morgentaler A.,Mens Health Boston | Conners W.P.,III
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. Source

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. Source

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