Testosterone Replacement in Androgen-Deficient Men With Ejaculatory Dysfunction: A Randomized Controlled Trial

Abstract

Context: 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.

Objective: To evaluate the efficacy of T replacement in androgen-deficient men with EjD.

Design: A multicenter, double-blind, randomized, placebo-controlled, 16-week trial with T solution 2% versus placebo.

Setting: Medical centers in the United States, Canada, and Mexico.

Patients or other participants: 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 <300 ng/dL (<10.41 nmol/L) measured with liquid chromatography tandem mass spectrometry.

Interventions: Sixty milligrams of T solution 2% or placebo applied to the axillae for 16 weeks.

Main outcome measures: 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.

Results: 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.

Conclusion: T replacement was not associated with significant improvement in EjD in androgen-deficient men.

Trial registration: ClinicalTrials.gov NCT01419236.