Low T levels have been associated with ejaculatory dysfunction (EjD) in cross-sectional studies; however, the efficacy of T replacement in improving EjD has not been studied in a randomized controlled trial.
To evaluate the efficacy of T replacement in androgen-deficient men with EjD.
A multicenter, double-blind, randomized, placebo-controlled, 16-week trial with T solution 2% versus placebo.
Medical centers in the United States, Canada, and Mexico.
Seventy-six men with one or more EjD symptoms, including delayed ejaculation, anejaculation, reduced ejaculate volume, and/or reduced force of ejaculation, and two total T levels
Sixty milligrams of T solution 2% or placebo applied to the axillae for 16 weeks.
The primary outcome was a change in the score of the three-item Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF); secondary outcomes included measured ejaculate volume, scores of the bother/satisfaction item of the MSHQ-EjD-SF, the orgasmic function domain of the International Index of Erectile Function Questionnaire, and the sexual activity log.
Seventy-six participants were randomized; 66 completed the study. Baseline demographic and clinical characteristics were comparable between the treatment arms. T replacement improved the MSHQ-EjD-SF score (mean score change, +3. 1); however, this effect was not statistically different from placebo (mean score change, +2. 5; P = . 596). No differences were seen in any of the secondary outcomes or frequency of adverse events.
T replacement was not associated with significant improvement in EjD in androgen-deficient men.
The Journal of clinical endocrinology and metabolism. 2015 Jul 09 [Epub]
Darius A Paduch, Paula K Polzer, Xiao Ni, Shehzad Basaria
Department of Urology (D. A. P. ), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P. K. P. , X. N. ), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S. B. ), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115. , Department of Urology (D. A. P. ), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P. K. P. , X. N. ), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S. B. ), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115. , Department of Urology (D. A. P. ), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P. K. P. , X. N. ), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S. B. ), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115. , Department of Urology (D. A. P. ), Weill Cornell Medical College, New York, New York 10065; Lilly Research Laboratories (P. K. P. , X. N. ), Eli Lilly and Company, Indianapolis, Indiana 46285; and Section on Men's Health, Aging, and Metabolism (S. B. ), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115.