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Testosterone Replacement in Androgen-Deficient Men With Ejaculatory Dysfunction: A Randomized Controlled Trial.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2015 Aug; Vol. 100 (8), pp. 2956-62. Date of Electronic Publication: 2015 Jul 09. - Publication Year :
- 2015
-
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.<br />Objective: To evaluate the efficacy of T replacement in androgen-deficient men with EjD.<br />Design: A multicenter, double-blind, randomized, placebo-controlled, 16-week trial with T solution 2% versus placebo.<br />Setting: Medical centers in the United States, Canada, and Mexico.<br />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.<br />Interventions: Sixty milligrams of T solution 2% or placebo applied to the axillae for 16 weeks.<br />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.<br />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.<br />Conclusion: T replacement was not associated with significant improvement in EjD in androgen-deficient men.
- Subjects :
- Adult
Double-Blind Method
Ejaculation drug effects
Eunuchism blood
Eunuchism complications
Eunuchism epidemiology
Humans
Male
Middle Aged
Patient Satisfaction statistics & numerical data
Placebos
Sexual Dysfunction, Physiological blood
Sexual Dysfunction, Physiological epidemiology
Sexual Dysfunction, Physiological etiology
Testosterone blood
Androgens deficiency
Eunuchism drug therapy
Hormone Replacement Therapy
Sexual Dysfunction, Physiological drug therapy
Testosterone therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1945-7197
- Volume :
- 100
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 26158605
- Full Text :
- https://doi.org/10.1210/jc.2014-4434