Testosterone Replacement in Androgen-Deficient Men With Ejaculatory Dysfunction: A Randomized Controlled Trial.
J Clin Endocrinol Metab
; 100(8): 2956-62, 2015 Aug.
Article
in En
| MEDLINE
| ID: mdl-26158605
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 OTHERPARTICIPANTS:
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 OUTCOMEMEASURES:
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Sexual Dysfunction, Physiological
/
Testosterone
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Hormone Replacement Therapy
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Eunuchism
/
Androgens
Type of study:
Clinical_trials
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Etiology_studies
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Observational_studies
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Risk_factors_studies
Limits:
Adult
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Humans
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Male
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Middle aged
Language:
En
Journal:
J Clin Endocrinol Metab
Year:
2015
Document type:
Article
Affiliation country:
Bolivia