Impact on Erectile Function and Sexual Quality of Life of Couples: A Double-Blind, Randomized, Placebo-Controlled Trial of Tadalafil Taken Once Daily

Abstract

Introduction Clinical research on erectile dysfunction (ED) has focused primarily on the male and the impact of treatment on their erectile function (EF) and sexual quality of life. However, ED affects the quality of life of both the male and the female partner. The literature examining the impact on the female partner resulting from treating the male’s ED is somewhat limited. Aims To determine the efficacy of tadalafil 5 mg taken once daily compared with placebo on men’s EF and sexual quality of life, and to determine the impact of this treatment on the female partner’s sexual quality of life. Main Outcome Measures The co-primary outcome measures for this study were changes from baseline to end point in the EF domain of the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) question 2 (SEP-2) and question 3 (SEP-3), and the Sexual Quality of Life (SQoL) domain of the Sexual Life Quality Questionnaire (SLQQ) (subject and partner). Methods Following a 4-week treatment-free run-in phase, 342 subjects and their partners were randomly assigned to either placebo (N = 78) or tadalafil 5 mg (N = 264) for 12 weeks. The subjects’ and partners’ responses to study measures were collected throughout the study. Results Compared with placebo, tadalafil-treated subjects showed a significant improvement on efficacy measures (P < 0.001) including changes in the IIEF-EF, SEP-2 and SEP-3. In addition, the sexual quality of life of men and their female partners, as measured by the SQoL domain, was significantly improved with tadalafil 5 mg taken once daily (P < 0.001) compared with placebo. Conclusions Tadalafil 5 mg once daily significantly improved EF and sexual quality of life for men with ED. In addition, the sexual quality of life of the female partners of the men treated with tadalafil was significantly improved.

Improvements in confidence, sexual relationship and satisfaction measures: results of a randomized trial of tadalafil 5 mg taken once daily

“…9 With an estimated 30% initial screening failure rate and an expected 20% drop out rate after randomization, a total of 450 participants were required for screening to ensure that 320 participants were randomized to either tadalafil 5 mg or placebo and 250 participants completed the study. This sample size provided at least 95% power to detect treatment group differences in mean change from baseline of 7.5 points, 25% and 30% in IIEF-EF, SEP2 and SEP3 between participants treated with tadalafil 5 mg vs placebo, assuming a common standard deviation of 10 points, 35% and 40%, respectively.…”

“…9 The psychosocial outcomes and sexual satisfaction results for the participant and his partner are reported here. This 12-week study of tadalafil 5 mg once daily was completed in January 2008 at 26 sites in Austria, Germany, France, Mexico and the United States in accordance with regulatory standards of Good Clinical Practice and the Declaration of Helsinki (1996).…”

“…Most adverse events were mild to moderate in severity and were consistent with previous studies of once daily dosing. 9,19 The percentage of participants who completed the study was slightly higher in the tadalafil (92%) vs placebo (82%) group, and the most common reason for discontinuation was participant decision (tadalafil, 8 participants; placebo, 12 participants). No participant in the placebo group and three (1%) participants in the tadalafil group discontinued owing to adverse events.…”

“…9 The mean age of all participants was 54 (s.d. ¼ 10) years, and most participants had ED for at least 1 year (Table 1).…”

“…9 The mean increase in SLQQ-QoL scores for tadalafiltreated participants (27 to 66) was significantly greater than that for the placebo (28 to 40) (Po0.001). Similarly, the mean increase in scores among the female partners of tadalafil-treated participants (35 to 67) was significantly greater compared with placebo (39 to 44) (Po0.001).…”