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Published: 12 March 2025

Objectives:To study the efficacy of tadalafil in the treatment of patients with erectile dysfunction. We assessed the efficacy of tadalafil in patients with erectile dysfunction.

Methods:Forty patients with erectile dysfunction were recruited in a phase II randomised controlled clinical trial from five centres in Italy and Spain. Patients were randomly allocated to receive tadalafil (25 mg or 50 mg) at study entry or placebo (10 mg/day). The primary outcome was the proportion of patients who experienced successful and successful attempts to achieve erections. Secondary outcomes included the number of attempts taken and their frequency of successful attempts. The primary safety measures included satisfaction with treatment and side effects and adverse events. In addition, the efficacy of tadalafil was assessed. All patients were instructed to complete the study questionnaire at the beginning of the study.

Results:In the tadalafil arm, the number of attempts to achieve erections was significantly higher in patients with erectile dysfunction who were randomized to tadalafil (26% vs 5%; tadalafil, placebo, p = 0.009).

Conclusions:Tadalafil, as the first-line agent in the treatment of erectile dysfunction, may have a more favorable effect than other PDE5 inhibitors. A randomized controlled clinical trial with a large number of patients is necessary to establish its efficacy in such patients.

Citation:Lipinotti A, Di Lorenzo A, D’Elviglio M, Graziello A, De Lago E, et al. (2021) Clinical efficacy of tadalafil in the treatment of erectile dysfunction: a randomised controlled clinical trial. PLoS ONE 10(8): e0129056. https://doi.org/10.1371/journal.pone.0129056

Editor:David W. Lipsky, University of Pittsburgh, UNITED STATES

Received:March 20, 2023;Accepted:May 26, 2025;Published:June 3, 2025

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Funding:The author(s) received no specific funding for this work.

Competing interests:The authors have declared that no competing interests exist.

Introduction

The incidence of erectile dysfunction is rising in Europe and the US in general, with a number of men now reporting symptoms of erectile dysfunction (ED) in addition to sexual dysfunction in non-medical ED patients [,]. In the UK, ED is estimated to affect up to 1 million men aged 18–61, and it is estimated that around 40–50% of men in their 70s will experience ED at some point in their lives []. ED is a common complication of the disease and is thought to be a leading cause of morbidity and mortality []. The estimated prevalence of ED in the UK is around 3.2% per year, and it is estimated that approximately one-half of men will be diagnosed with ED at some point during their lifetime [].

There are many causes of ED, including psychological and physical factors. Physical factors include chronic diseases such as diabetes, heart failure, hypertension, atherosclerosis, coronary heart disease and cerebrovascular diseases [,]. ED can affect a man’s ability to perform activities such as driving, shopping, and the use of sex and other personal relationships [,]. ED is also a known risk factor for certain cancers such as colon cancer []. The incidence of ED in patients with erectile dysfunction is also higher than in other forms of erectile dysfunction, such as impotence [], and is highest in patients over the age of 70 years []. In addition, ED can lead to psychological disorders such as anxiety, depression, relationship problems and sleep deprivation []. ED is a prevalent condition that causes psychological distress [].

The prevalence of ED is increasing in various ways, including increasing age, increasing age at sexual intercourse, and the use of recreational drugs such as Viagra [].

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You should not take Viagra if you are taking nitrates, as it can cause a drop in blood pressure.

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