Tadalafil and Fluoxetine in Premature Ejaculation: Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Abstract

Introduction: Premature ejaculation (PE) is a common male sexual disorder. An ideal, reliable and effective treatment is desired by many men and couples affected by this condition. Aim: Evaluate if the association of a phosphodiesterase-5 inhibitor, tadalafil, and a selective serotonin reuptake inhibitor, fluoxetine, can prolong the intravaginal ejaculatory latency time (IELT) in men with lifelong premature ejaculation. Methods: Sixty patients with lifelong premature ejaculation and without erectile dysfunction (ED) with IELT less than 90 s were enrolled in the protocol and randomized into 4 groups to use a combination of medications: (1) tadalafil 20 mg plus fluoxetine 90 mg, (2) fluoxetine 90 mg plus placebo, (3) tadalafil 20 mg plus placebo, and (4) two different placebo capsules (control). Before starting the medications, each man timed his IELT with a stopwatch, and likewise during the treatment period. Fluoxetine 90 mg or placebo was taken once a week plus tadalafil 20 mg or placebo within a 36-hour frame of intended sexual intercourse with a steady partner. Patients were prospectively followed for 12 weeks. One-way ANOVA was used for statistical comparisons of IELT results in each group. Results: Mean IELT before starting treatment was 51.3 ± 23 s. Withone-way ANOVA, a statistically significant difference in post-treatment IELT was seen with combination treatment compared to placebo (p < 0.001). There were increases in IELT from baseline in patients using fluoxetine plus tadalafil (49.57 ± 25.87 to 336.13 ± 224.77) (p < 0.001), fluoxetine (56.55 ± 18.55 to 233.62 ± 105.08) (p < 0.001) and tadalafil (49.26 ± 19.43 to 186.53 ± 159.05) (p = 0.001). The increases in each group were statistically significant compared to the placebo (49.86 ± 19.43 to 67.82 ± 46.18) (p = 0.042). Conclusion: Fluoxetine plus tadalafil significantly increased the IELT from baseline in men with lifelong premature ejaculation when compared to placebo, tadalafil or fluoxetine.

Methods for a rapid systematic review and metaanalysis in evaluating selective serotonin reuptake inhibitors for premature ejaculation

“…A total of 41 RCTs that evaluated an SSRI against a comparator (placebo, no therapy, another SSRI, or another agent) were identified and were included in both the rapid review for the HTA short report and the full systematic review. Twenty-five of these RCTs (Atmaca et al 2002;Atmaca et al 2003;Biri et al 1998;Buvat et al 2009;Kara et al 1996;Kaufman et al 2009;Manasia et al 2003;Mattos et al 2008;McMahon 1998;McMahon et al 2010;Mendels et al 1995;Murat Basar et al 1999;Panshou and Xie 2004;Pryor et al 2006;Safarinejad and Hosseini 2006;Safarinejad 2008;Safarinejad 2006;Waldinger et al 1994;Waldinger et al 1997;Waldinger et al 1998;Waldinger et al 2001a;Waldinger et al 2001b;Waldinger et al 2003;Yilmaz et al 1999;Zhou 2007) had been previously included by eleven systematic reviews ( Data from these 25 RCTs were extracted from the systematic reviews they were reported in for the rapid review, and directly from the RCT publication obtained in full for the full systematic review.…”

Is there a role for phosphodiesterase type-5 inhibitors in the treatment of premature ejaculation?

“…Another study was designed to investigate the efficacy of tadalafil 20 mg on IELT in men with LL-PE, taken before intercourse in association with SSRI taken once a week (fluoxetine 90 mg) or alone. 46 The authors found that the increase in IELT was greater in patients who used fluoxetine 90 mg taken once a week and tadalafil 20 mg before sexual relations, when compared with placebo, fluoxetine or tadalafil alone. However, this study had no crossover of the groups that would probably allow better understanding of whether such results remained consistent.…”

Interventions to treat premature ejaculation: a systematic review short report

“…39,41,141,166 A further 16 RCTs additional to those already included reviews were identified for inclusion, [92][93][94][95][96][97][98][99][100][101][102][103][104][105][106][107] resulting in a total of 42 RCTs that evaluated SSRIs. Fourteen of the 16 additional RCTs identified by the literature search were considered to be at overall unclear risk of bias.…”