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Improved Sexual Function with Testosterone Replacement Therapy in Hypogonadal Men: Real-World Data from the Testim Registry in the United States (TRiUS).
MedLine Citation:
PMID:  21834870     Owner:  NLM     Status:  Publisher    
Introduction.  Up to 30% of erectile dysfunction (ED) patients treated with phosphodiesterase type 5 (PDE5) inhibitors do not show improved sexual function, which may be due in part to low serum testosterone. Hypogonadal patients already receiving testosterone replacement therapy (TRT) likewise can still suffer from symptoms of sexual dysfunction. In these patient populations, augmenting with, or switching, TRT treatment may improve sexual function. Aim.  To determine if 12-month treatment with a testosterone gel improves sexual function in hypogonadal men, as measured by the Brief Male Sexual Function Inventory (BMSFI), and in subgroups defined by low testosterone, PDE5 inhibitor use, and prior TRT. Methods.  The Testim Registry in the United States (TRiUS) was a large (N = 849) multicenter registry of hypogonadal men treated with Testim (testosterone 1%) topical gel and followed for 12 months. Main Outcome Measures.  Data collected at suggested visits (baseline; 1, 3, 6, and 12 months) included total testosterone (TT), free testosterone (FT), BMSFI scores, physical exam, and body measurements. Results.  TRiUS had 271 patients with baseline testosterone and BMSFI measurements. At 12 months of TRT, TT and FT levels significantly increased from baseline (P < 0.001), with mean ± standard deviation final TT = 17.37 ± 8.61 nmol/L (500.6 ± 248.2 ng/dL) and FT = 240.1 ± 296.0 pmol/L (69.2 ± 85.3 pg/mL). The mean total BMSFI score significantly increased from baseline at 12 months (27.4 ± 10.3 to 33.8 ± 9.8, P < 0.001) and at each visit in all domains (sex drive/libido, erectile function, ejaculatory function, level of bother), overall and for all subgroups. Regression analysis indicated that increased total BMSFI score was significantly associated with increased TT levels at 6 months. Conclusions.  In hypogonadal patients, 12-month administration of topical testosterone gel resulted in increased TT and FT levels and significantly improved sexual function. All subgroups studied, including men taking PDE5 inhibitors for ED and those previously on TRT, demonstrated significant improvement in sexual function from baseline scores. Khera M, Bhattacharya RK, Blick G, Kushner H, Nguyen D, and Miner MM. Improved sexual function with testosterone replacement therapy in hypogonadal men: Real-world data from the Testim Registry in the United States (TRiUS). J Sex Med **;**:**-**.
Mohit Khera; Rajib K Bhattacharya; Gary Blick; Harvey Kushner; Dat Nguyen; Martin M Miner
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-8-11
Journal Detail:
Title:  The journal of sexual medicine     Volume:  -     ISSN:  1743-6109     ISO Abbreviation:  -     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-8-12     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101230693     Medline TA:  J Sex Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2011 International Society for Sexual Medicine.
Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA Circle Medical LLC, Norwalk, CT, USA Department of Biometrics, Auxilium Pharmaceuticals, Malvern, PA, USA Department of Medical Affairs, Auxilium Pharmaceuticals, Malvern, PA, USA Miriam Hospital Men's Health Center, Warren Alpert School of Medicine, Brown University, Providence, RI, USA.
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