Testosterone replacement therapy did not appear to improve sexual function in men with low testosterone levels who have ejaculatory disorders, according to study results published in the Journal of Clinical Endocrinology & Metabolism.
“Ejaculatory dysfunction constitutes a spectrum of ejaculatory symptoms such as delayed ejaculation, anejaculation, retrograde ejaculation, reduction in ejaculate volume, and decreased force of ejaculation,” Darius A. Paduch, MD, PhD, of New York-Presbyterian Hospital/Weill Cornell Medical Center and Weill Cornell Medical College in New York, and colleagues wrote.
About 10% to 18% of men are estimated to have ejaculatory dysfunction, which differs from erectile dysfunction, but there are no currently FDA-approved treatments for the condition. The causes may be neurobiological, physiological or psychological, the researchers noted, with some evidence showing that men with low testosterone are nearly twice as likely to experience ejaculatory dysfunction.
As a result, Paduch and colleagues sought to determine whether testosterone therapy would be beneficial for men with low testosterone who are experiencing these problems.
“This is the first clinical trial examining the treatment of a very common but poorly understood condition that affects men’s physical health as well as their interpersonal relationships,” Paduch said in a press release.
“Although the participants in this study did not experience any significant improvement in ejaculatory function, we hope our work will spur the development of additional clinical trials to find treatments for this condition.”
The study was a multicenter, double-blind, placebo-controlled trial involving 76 men, all aged older than 26 years, with one or more symptoms of ejaculatory dysfunction and two total testosterone levels less than 300 ng/dL. Participants were randomly assigned to receive a 2% testosterone solution applied on the skin or placebo for 16 weeks. Sixty-six men completed the study.
Testosterone levels were measured throughout the study and ejaculatory function was assessed via semen samples and sexual health questionnaires and logs.
A change in the score of the three-item Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHG-EjD-SF) served as the primary outcome. Secondary outcomes included ejaculate volume, scores of the bother/satisfaction item of the MSHQEjD-SF, the orgasmic function domain of the International Index of Erectile Function Questionnaire and the sexual activity log.
Results indicated that testosterone replacement improved MSHQ-EjD-SF score by a mean of 3.1, yet the change did not differ significantly from that seen with placebo (mean score change, 2.5; P=.596). There was also little to no improvement in ejaculate volume or orgasmic function between groups.
The researchers noted that testosterone therapy was not effective in all of the men who received the treatment, which may account for the lack of improvement.
About 70% of the men who received the treatment experienced an increase in testosterone levels above 300 ng/dL, according to Paduch, with a subsequent analysis showing that those men had statistically significant improvement in ejaculatory function vs. those whose testosterone levels did not exceed 300 ng/dL.
“Our findings suggest physicians who are treating men with ejaculatory dysfunction need to look at other reasons for delayed ejaculation than hypogonadism,” study co-author Shehzad Basaria, MD, of Brigham and Women’s Hospital and Harvard Medical School in Boston, said in the release.
“More research is needed to determine whether a longer course of testosterone therapy or other treatment options can benefit men with ejaculatory dysfunction.”