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No AccessJournal of UrologyAdult Urology1 Mar 2016

Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study

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    Purpose:

    We determined the effect of testosterone solution 2% on total testosterone level and the 2 symptoms of hypogonadism, sex drive and energy level.

    Materials and Methods:

    This was a randomized, multicenter, double-blind, placebo controlled, 16-week study to compare the effect of testosterone and placebo on the proportion of men with a testosterone level within the normal range (300 to 1,050 ng/dl) upon treatment completion. We also assessed the impact of testosterone on sex drive and energy level measured using SAID (Sexual Arousal, Interest and Drive scale) and HED (Hypogonadism Energy Diary), respectively. A total of 715 males 18 years old or older with total testosterone less than 300 ng/dl and at least 1 symptom of testosterone deficiency (decreased energy and/or decreased sexual drive) were randomized to 60 mg topical testosterone solution 2% or placebo once daily.

    Results:

    Of study completers 73% in the testosterone vs 15% in the placebo group had a testosterone level within the normal range at study end point (p <0.001). Participants assigned to testosterone showed greater baseline to end point improvement in SAID scores (low sex drive subset p <0.001 vs placebo) and HED scores (low energy subset p = 0.02 vs placebo, not significant at prespecified p <0.01). No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group. The incidence of increased hematocrit was higher with testosterone vs placebo (p = 0.04).

    Conclusions:

    Once daily testosterone solution 2% for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive in hypogonadal men. Improvement was also seen in energy levels on HED though not at the prespecified p <0.01. No new safety signals were identified.

    References

    • 1 : Testosterone replacement therapy faces FDA scrutiny. JAMA2015; 313: 563. Google Scholar
    • 2 Joint Meeting for Bone, Reproductive and Urologic Drugs Advisory Committee (Brudac) and The Drug Safety and Risk Management Advisory Committee (Dsarm Ac) September 17, 2014. Available at http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/reproductivehealthdrugsadvisorycommittee/ucm412536.pdf. Accessed April 3, 2015. Google Scholar
    • 3 : Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf)2011; 75: 836. Google Scholar
    • 4 : A simple self-report diary for assessing psychosexual function in hypogonadal men. J Androl2003; 24: 688. Google Scholar
    • 5 : Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab2000; 85: 2839. Google Scholar
    • 6 : Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men. J Clin Endocrinol Metab1999; 84: 3469. Google Scholar
    • 7 United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. December 2009. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed April 3, 2015. Google Scholar
    • 8 : Experiences and treatment patterns of hypogonadal men in a U.S. health system. Int J Clin Pract2014; 68: 1257. Google Scholar
    • 9 : Andropause and quality of life: findings from patient focus groups and clinical experts. Maturitas2002; 43: 231. Google Scholar
    • 10 : Establishing the content validity of the Sexual Arousal, Interest, and Drive Scale and the Hypogonadism Energy Diary. Int J Clin Pract2015; 69: 454. Google Scholar
    • 11 : Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol2012; 12: 30. Google Scholar
    • 12 : Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol2003; 189: 98. Google Scholar
    • 13 : The International Index of Erectile Function (IIEF): a multidimensional scale for the assessment of erectile dysfunction. Urology1997; 49: 822. Google Scholar
    • 14 : Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. Biom J2011; 53: 894. Google Scholar
    • 15 : Testosterone supplementation and sexual function: a meta-analysis study. J Sex Med2014; 1: 1577. Google Scholar
    • 16 : Effects of testosterone on sexual function in men: results of a meta-analysis. Clin Endocrinol (Oxf)2005; 63: 381. Google Scholar
    • 17 : AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. J Clin Endocrinol Metab2003; 88: 2673. Google Scholar
    • 18 : A 6-month observational study of energy, sexual desire, and body proportions in hypogonadal men treated with a testosterone 1% gel. Aging Male2014; 17: 1. Google Scholar
    • 19 : IPASS: a study on the tolerability and effectiveness of injectable testosterone undecanoate for the treatment of male hypogonadism in a worldwide sample of 1,438 men. J Sex Med2013; 10: 579. Google Scholar
    • 20 : Testosterone alters iron metabolism and stimulates red blood cell production independently of dihydrotestosterone. Am J Physiol Endocrinol Metab2014; 307: E456. Google Scholar
    • 21 : Adverse events associated with testosterone replacement in middle-aged and older men: a meta-analysis of randomized, placebo-controlled trials. J Gerontol A Biol Sci Med Sci2005; 60: 1451. Google Scholar
    • 22 : Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med2011; 8: 2079. Google Scholar
    • 23 : Testosterone and prostate cancer: what are the risks for middle-aged men?. Urol Clin North Am2011; 38: 119. Google Scholar
    • 24 : The role of testosterone therapy in cardiovascular mortality: culprit or innocent bystander?. Curr Atheroscler Rep2015; 17: 490. Google Scholar
    • 25 : Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Expert Opin Drug Saf2014; 13: 1327. Google Scholar
    • 26 : Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One2014; 9: e85805. Google Scholar
    • 27 : Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA2013; 310: 1829. Google Scholar
    • 28 Food and Drug Administration Drug Safety Communication: FDA Cautions about Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack and Stroke with Use. March 3, 2015. Available at http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm. Accessed April 3, 2015. Google Scholar
    • 29 : The testosterone trials: seven coordinated trials of testosterone treatment in elderly men. Clin Trials2014; 11: 362. Google Scholar
    • 30 : Baseline data from the TRiUS registry: symptoms and comorbidities of testosterone deficiency. Postgrad Med2011; 123: 17. Google Scholar
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