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Introduction: A new formulation of testosterone gel (1.62% testosterone gel) with increased viscosity and reduced volume of application has been shown to be safe and efficacious after 182 days of use in a phase 3, double-blind study in adult hypogonadal males., Aim: The objective of this study was to evaluate the efficacy and safety of the 1.62% testosterone gel after daily application to the skin in a 182-day (6-month) open-label extension of the initial 182-day double-blind study., Methods: One hundred and sixty-three subjects, aged 26 to 77 years, continued on active (Continuing Active subjects) 1.62% testosterone gel for the remainder of the study (364 days total). In 28 subjects who had previously received placebo (Formerly Placebo subjects), the dose was titrated to normal levels of serum total testosterone (300-1,000 ng/dL). Dose adjustments for both groups were allowed at specific visits to maintain serum testosterone within a normal range., Main Outcome Measure: The main outcome measure was the percentage of subjects with serum total testosterone average concentrations (C(av) ) within the normal range at day 364., Results: On day 364, 77.9% (95% confidence interval: 70.0, 84.6) of the Continuing Active subjects and 87.0% (66.4, 97.2) of the Formerly Placebo subjects had C(av) values within the eugonadal range. The 1.62% testosterone gel was safe and well tolerated in this study., Conclusion: Treatment with 1.62% testosterone gel for up to 1 year (182 days for the Formerly Placebo subjects, 364 days for the Continuing Active subjects) was safe and efficacious, resulting in >77% of treated subjects achieving normal serum testosterone levels at final visit., (© 2012 International Society for Sexual Medicine.)

Introduction: Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels., Aim: To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days., Methods: This was a multicenter, randomized, double-blind, placebo-controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations <300 ng/dL and prostate-specific antigen <2.5 ng/mL. Topical testosterone gel (1.62%), 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel was applied once daily to either upper arms/shoulders or abdomen. Dose adjustments were made on days 14, 28, and 42. Main Outcome Measures.  The percentage of subjects with serum total testosterone average concentrations (C(av) ) within the normal range of 300-1,000 ng/dL on study days 14, 56, 112, and 182., Results: Following titration, significantly (P < 0.0001) more subjects receiving active treatment had testosterone C(av) values (range 81.6% to 82.5%) within the eugonadal range compared with placebo (range 28.6% to 37.0%) on all study days. The 1.62% gel was safe and well tolerated., Conclusions: In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels., (© 2011 International Society for Sexual Medicine.)

Purpose: We determined the pharmacokinetics and safety of 750 mg long acting testosterone undecanoate given intramuscularly at 0, 4 and 14 weeks to men with hypogonadism., Materials and Methods: A 24-week, single arm, open label, multicenter trial in 130 hypogonadal men 18 years or older who were screened for serum total testosterone less than 300 ng/dl was performed at 31 research sites in the United States between March and November 2007. Testosterone undecanoate (750 mg) was administered at baseline, and at weeks 4 and 14. Serum testosterone samples were collected on days 4, 7, 11, 14, 21, 28, 42, 56 and 70 following injection 3. Safety was assessed, eg biochemical markers and adverse events, secondary to testosterone undecanoate treatment., Results: Of the 130 patients 116 with a mean +/- SE age of 54.2 +/- 0.90 years completed the 24-week trial. Following the week 14 injection mean +/- SD average serum testosterone was 494.9 +/- 141.46 ng/dl during the 70-day dosing interval and mean +/- SD maximum serum testosterone was 890.6 +/- 345.11 ng/dl with a mean concentration within the young healthy adult male range (300 to 1,000 ng/dl) in 94% of patients and a mean maximum concentration of below 1,500 ng/dl in 92%. Mean +/- SE hematocrit and hemoglobin increased from baseline to week 24 (43.3% +/- 0.32% to 45.7% +/- 0.35% and 14.6 +/- 0.11 to 15.5 +/- 0.13 gm/dl, respectively). Mean +/- SE prostate specific antigen increased from baseline to 24 weeks (1.0 +/- 0.08 to 1.3 +/- 0.10 ng/ml). No prostate cancer or gynecomastia was observed during this 24-week study., Conclusions: This 24-week clinical study demonstrated that 750 mg testosterone undecanoate depot injection administered intramuscularly at 0, 4 and 14 weeks achieves serum testosterone levels in the normal range during a 10-week dosing interval.

Purpose: We documented the experience of 2 urology practices with the use of testosterone supplementation to treat hypogonadal men who had undergone curative radical prostatectomy for localized prostate cancer. We also reviewed the literature for reports of the use of testosterone in men surgically cured of prostate cancer., Materials and Methods: A retrospective review of clinical records of 2 busy private urology practices was used to compile brief case histories of hypogonadal men treated with testosterone who had undergone curative radical prostatectomy for localized prostate cancer. Using MEDLINE and BIOSIS Previews (Biological Abstracts, Inc., Philadelphia, Pennsylvania), the literature was searched for articles describing the use of testosterone in men surgically cured of organ confined prostate cancer., Results: The case records of 7 hypogonadal men who had undergone curative radical prostatectomy were identified. All men had clinical symptoms of hypogonadism and low serum testosterone levels. Each man was treated with an androgen preparation. After variable followup periods no biochemical or clinical evidence of cancer recurrence was found in any of the group. No reports in the literature were found of a similar therapeutic approach for such patients., Conclusions: Based on the clinical experience with this small group of men, and indirect evidence of the safety of this approach from epidemiological and clinical data, further cautious use of testosterone in a carefully selected population seems warranted.

Abstract: The evaluation and treatment of late-onset hypogonadism (LOH) is one of the manifold tasks of the urologist in daily practice. Diagnosis of LOH is based on an adequate history and physical examination as well as biochemical assessment of androgen deficiency. Treatment of hypogonadism with androgen therapy has been shown to be highly effective in re-establishing normal testosterone levels and maintaining libido, sexual function and improving muscle mass and bone mineral density. Recent pharmacological research has developed short-acting testosterone gel preparations and a 3-month depot injection. The possible development or unmasking of prostate cancer has long been a major concern in treating LOH. Consequently underlying prostate disease should be excluded by diagnostic measures before androgen therapy is initiated. Evidence suggests that provided hypogonadal men are carefully counselled and closely monitored during treatment testosterone therapy can be initiated after radical prostatectomy for non-metastatic prostate cancer with undetectable prostate specific antigen of long duration. [Copyright &y& Elsevier]