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OBJECTIVEThis study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS).RESEARCH DESIGN AND METHODSThe efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0−6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6−12).RESULTSTRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA1c: treatment difference, −0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate.CONCLUSIONSOver a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS.

Introduction.  The medical literature contains several definitions of premature ejaculation (PE). The most commonly quoted definition, the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders‐Fourth Edition‐Text Revision, and other definitions of PE are all authority based rather than evidence based, and have no support from controlled clinical and/or epidemiological studies. Aim.  The aim of this article is to develop a contemporary, evidence‐based definition of PE. Methods.  In August 2007, the International Society for Sexual Medicine (ISSM) appointed several international experts in PE to an Ad Hoc Committee for the Definition of Premature Ejaculation. The committee met in Amsterdam in October 2007 to evaluate the strengths and weaknesses of current definitions of PE, to critique the evidence in support of the constructs of ejaculatory latency, ejaculatory control, sexual satisfaction, and personal/interpersonal distress, and to propose a new evidence‐based definition of PE. Results.  The committee unanimously agreed that the constructs that are necessary to define PE are rapidity of ejaculation, perceived self‐efficacy and control, and negative personal consequences from PE. The committee proposed that lifelong PE be defined as “. . . a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration, and the inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.” This definition is limited to men with lifelong PE who engage in vaginal intercourse. The panel concluded that there are insufficient published objective data to propose an evidence‐based definition of acquired PE. Conclusion.  The ISSM definition of lifelong PE represents the first evidence‐based definition of PE. This definition will hopefully lead to the development of new tools and Patient Reported Outcome measures for diagnosing and assessing the efficacy of treatment interventions and encourage ongoing research into the true prevalence of this disorder and the efficacy of new pharmacological and psychological treatments. McMahon CG, Althof SE, Waldinger MD, Porst H, Dean J, Sharlip ID, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJG, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen RC, Rowland DL, and Segraves R. An evidenced‐based definition of lifelong premature ejaculation: Report of the International Society for Sexual Medicine (ISSM) Ad Hoc Committee for the definition of premature ejaculation. J Sex Med 2008;5:1590–1606.

Introduction Addition of testosterone (T) may improve the action of phosphodiesterase type 5 inhibitors (PDE5-Is) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels. Aims To confirm this add-on effect of T in men optimally treated with PDE5-Is and to specify the baseline T levels at which such an effect becomes significant. Methods A multicenter, multinational, double-blind, placebo-controlled study of 173 men, 45–80 years, nonresponders to treatment with different PDE5-Is, with baseline total T levels ≤4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel), to be increased to 10 mg T if results were clinically unsatisfactory. Main Outcomes Measures Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses (Sexual Encounter Profile 3 question). Results Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups. In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL, no additional effect of T administration to men optimally treated with PDE5-Is was encountered. The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤3 ng/mL. Conclusions The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks. Furthermore, addition of T to this PDE5-I regimen is beneficial, but only in hypogonadal men with baseline T levels ≤3 ng/mL.

Introduction The challenge in the field of sexual medicine is to develop evidence-based principles for clinical evaluation and create a uniform, widely accepted diagnostic and treatment approach for all sexual problems and dysfunctions, for both genders. Aim To provide recommendations for the broad approach for assessing sexual problems in a medical practice setting; to develop an evidence-based diagnostic and treatment algorithm for men and women with sexual dysfunctions. Methods The PubMed literature was reviewed. Expert opinion was based on the grading of evidence-based medical literature and the Delphi consensus process. Results The Committee determined three principles for clinical evaluation and management: (i) adoption of a patient-centered framework, with emphasis on cultural competence in clinical practice; (ii) application of evidence-based medicine in diagnostic and treatment planning; (iii) use of a unified management approach in evaluating and treating sexual problems in both men and women. The International Consultation in Sexual Medicine-5 stepwise diagnostic and treatment algorithm was developed for that purpose. According to this algorithm, sexual, medical, and psychosocial history is mandatory, whereas physical examination and laboratory tests are highly recommended in most cases. Furthermore, the Brief Sexual Symptom Checklist (BSSC) for Men and BSSC for Women, and more recently the Sexual Complaints Screener (SCS) for Men and SCS for Women, were all endorsed for screening purposes. A classification system was also defined; clinically, sexual dysfunctions are categorized in three types according to their etiology (Type I: psychogenic; Type II: organic; Type III: mixed). Final recommendations on specialized diagnostic tests were based on level of evidence. Conclusions A unified diagnostic and management strategy in sexual medicine, irrespective of condition and gender, would improve patients’ sexual well-being. It would also lead to the development of academic curricula to provide practicing physicians across specialties with the needed skills to meet contemporary patients’ needs in sexual medicine health-care delivery.