108 Impact of Endogenous Hormonal Status on Successful Treatment of Sexual Dysfunction in Men Taking Once-Daily Tadalafil 5mg for LUTS/BPH
Abstract
Controversy exists as to whether erectile response to phosphodiesterase type 5 inhibitors (PDE5i) is compromised in men with low total testosterone (TT) levels. This is amplified by reports of improved response to PDE5i therapy following co-administration of testosterone replacement therapy in hypogonadal men unresponsive to PDE5i therapy. The purpose of this analysis was to determine if baseline TT and luteinizing hormone (LH) levels influence the efficacy of tadalafil at endpoint (12 weeks) for erectile dysfunction in men with concomitant lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH). This integrated analysis included 1076 men randomized to once-daily tadalafil 5 mg (n=540) or placebo (n=536) for 12 weeks in 3 prospective clinical trials. Subjects were categorized at baseline by low vs normal TT (9.4 mIU/mL). Treatment-group differences (12-week mean changes) in International Index of Erectile Function (IIEF) domain scores by hormone subgroups were assessed using analysis of covariance (ANCOVA). The main outcome measure was change in the Erectile Function (EF) domain score.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,076 participants or records.
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