Abstract | INTRODUCTION: AIMS: METHODS: Sexually active, hypogonadal men at least 18 years old (total testosterone < 300 ng/dL) were randomized to receive testosterone or placebo for 12 weeks. MAIN OUTCOME MEASURES: Effects of testosterone on primary outcomes were evaluated using the International Index of Erectile Function (IIEF) and the Men's Sexual Health Questionnaire, Ejaculatory Dysfunction, Short Form (MSHQ-EjD-SF) questionnaires. Treatment differences were calculated using analysis of covariance. RESULTS: In total, 715 men (mean age = 55 years) were randomized to placebo (n = 357) or testosterone (n = 358). Most sexually active men who reported IIEF scores had some degree of erectile dysfunction (IIEF erectile function score < 26). Although ejaculatory function score (MSHQ-EjD-SF) improved in the testosterone group compared with placebo (P < .001), improvement on the "bother" item did not reach statistical significance. Treatment-related adverse events in the testosterone group affecting at least 1% of patients were increased hematocrit, upper respiratory tract infection, arthralgia, burning sensation, fatigue, increased prostate-specific antigen, erythema, and cough. Few patients in either treatment group developed at least one adverse event leading to discontinuation (testosterone = 1.98% vs placebo = 3.09%; P = .475). CONCLUSION: Hypogonadal men receiving testosterone solution 2% therapy experience significantly greater improvement in ejaculatory function, compared with placebo, as assessed by the MSHQ-EjD-SF. However, improvement in "bother" was not statistically different between the two groups. Testosterone therapy was generally well tolerated.
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Authors | Mario Maggi, Darell Heiselman, Jack Knorr, Smriti Iyengar, Darius A Paduch, Craig F Donatucci |
Journal | The journal of sexual medicine
(J Sex Med)
Vol. 13
Issue 8
Pg. 1220-6
(08 2016)
ISSN: 1743-6109 [Electronic] Netherlands |
PMID | 27436077
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Androgens
- Testosterone
- Prostate-Specific Antigen
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Topics |
- Adult
- Aged
- Androgens
(administration & dosage)
- Drug Administration Schedule
- Ejaculation
(drug effects)
- Erectile Dysfunction
(drug therapy)
- Humans
- Hypogonadism
(drug therapy)
- Male
- Men's Health
- Middle Aged
- Orgasm
(drug effects)
- Penile Erection
(drug effects)
- Prostate-Specific Antigen
(metabolism)
- Sexual Behavior
(physiology)
- Surveys and Questionnaires
- Testosterone
(administration & dosage)
- Treatment Outcome
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