At week 4, significantly greater percentages of men being treated with Cialis 2.5 to 5 mg and 5 mg (33.5 percent and 41.1 percent, respectively) had experienced a return to normal erectile function (placebo, 8.5 percent both, p <. Treatment with Cialis 2.5 mg to 5 mg and 5 mg met the primary endpoint, resulting in significantly higher percentages of men (38.7 percent and 39.6 percent, respectively) with IIEF-EF domain scores in the normal range ( > /= 26) through 12 weeks versus placebo (12.1 percent both, p <. The International Index of Erectile Function-Erectile Function Domain (IIEF-EF) is a questionnaire evaluating sexual function where higher scores indicate better erectile function. The key secondary objective was evaluation of the efficacy of tadalafil 2.5 titrated to 5 mg and 5 mg once daily compared to placebo, as measured by change from baseline to endpoint in IIEF-EF. The primary objective was to determine whether a significantly greater percentage of incomplete responders had a return to normal erectile function when treated with tadalafil 2.5 titrated to 5 mg and 5 mg once daily compared to placebo. A total of 623 subjects were randomly assigned to receive treatment with Cialis for once daily use or placebo. The study assessed whether Cialis for once daily use is superior to placebo in returning these men to normal erectile function. The study enrolled men with ED aged 18 years and older who had some response (IIEF-EF > /= 17) but were unable to reach normal erectile function (IIEF-EF < 26) while on a maximum dose of an as-needed PDE5 inhibitor treatment. The randomized, double-blind, parallel, placebo-controlled trial was conducted in 51 sites in the United States and Canada. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away. It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure or if allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. ![]() "We believe the study outcome will help prescribers make better informed decisions when treating their patients." Kim, MD, of the Division of Urology, Department of Surgery, University of Tennessee Graduate School of Medicine and lead author of the study. "PDE5 inhibitors are highly effective for most men when taken as-needed, but responses can range from minimal change to a return to normal erectile function," said Dr. ![]() In a pre-specified secondary measure, Cialis significantly improved erectile function scores versus placebo in those men who had an incomplete response to as-needed PDE5 treatment.Ĭialis is a phosphodiesterase type 5 inhibitor approved by the Food and Drug Administration (FDA) for erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH) and both ED and the signs and symptoms of BPH (ED+BPH). INDIANAPOLIS, J/PRNewswire/ - Eli Lilly and Company (NYSE: LLY) announced today that study results published in the Journal of Sexual Medicine showed a greater percentage of men who had an incomplete response to as-needed PDE5 inhibitor treatment returned to normal erectile function when given Cialis once daily, compared to placebo, as measured by the erectile function domain of the International Index of Erectile Function (IIEF-EF).
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