Efficacy and Safety of Once-Daily Tadalafil in Men with Erectile Dysfunction Who Reported No Successful Intercourse Attempts at Baseline


  • Funding statement. The four base studies and the reported analysis were sponsored by Eli Lilly and Company (Lilly USA, LLC; Indianapolis, IN, USA).

  • Previous presentation. Selected findings were presented at the Sexual Medicine Society of North America 2011 Annual Fall Meeting, Las Vegas, NV, USA, November 10–13, 2011 (Moderated Poster 129).

  • ClinicalTrials.gov registration. Internal study identifiers H6D-MC-LVFZ (Clinicaltrials.gov identifier NCT00547183); H6D-MC-LVFP (NCT00381732); H6D-MC-LVGH (NCT00422734); and H6D-MC-LVCV (non–US trial; no NCT #).

Ridwan Shabsigh, MD, Division of Urology, Maimonides Medical Center, 904 49th Street, New York, NY 11219, USA. Tel: 718-283-7746; Fax: 718-283-7424; E-mail: rshabsigh@gmail.com


Introduction.  Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with “complete ED” are unclear.

Aim.  To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline.

Methods.  Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5 mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 “yes” responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period.

Main Outcome Measures.  Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models.

Results.  Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (±standard deviation) age was 58.2 ± 10.7 years; and most subjects had ED for ≥1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5 mg and to 46.4% with tadalafil 5 mg (each P < 0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5 mg and from 24.4% to 66.2% with 5 mg (each P < 0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5 mg and from 10.7 to 19.2 with 5 mg (each P < 0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo.

Conclusions.  The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5 mg and 5 mg, respectively, in men with no successful intercourse attempts at baseline. Shabsigh R, Seftel AD, Kim ED, Ni X, and Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med 2013;10:844–856.