Efficacy: For Use as Needed
CIALIS for use as needed can deliver fast onset and efficacy for up 36 hours- 16-minute onset in 32% of men taking CIALIS 20 mg (n=75) vs 15% taking placebo (n=74), P<0.05*1,2
- 30-minute onset in 52% of men taking CIALIS 20 mg vs 35% taking placebo, P<0.05*1,2
- Efficacy for successful intercourse for up to 36 hours3-5
- In a separate study designed to assess the efficacy of CIALIS at 36 hours, 62% of intercourse attempts were successful at 36 hours after dosing with CIALIS 20 mg vs 33% with placebo (P<0.001)†4,5

- *Onset defined as the earliest time to a successful erection (at least 1 erection in 4 attempts that led to successful intercourse).
- In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a single dose of CIALIS. CIALIS was shown to improve, compared to placebo, the ability of men with ED to have a single, successful intercourse attempt at each of these time points. Multiple attempts after a single dose were not evaluated in these studies.
- †Rates based on mean per-patient intercourse success. Men (n=483) were instructed to attempt intercourse 36 hours after dosing (33 to 39 hours).
- ‡Results from 5 randomized, 12-week, double-blind, placebo-controlled studies. Data are based on retrospective analysis of intercourse success at selected intervals with CIALIS 20 mg,CIALIS 10 mg, or placebo. Men were instructed to take 1 dose of treatment before sexual activity, with no food restrictions, and were free to choose when to attempt intercourse after dosing.
- §Rates based on mean per-patient intercourse success. Men (n=483) were instructed to attempt intercourse 36 hours after dosing (33 to 39 hours).
Satisfaction with erection hardness
CIALIS for use as needed delivered high patient satisfaction with erection hardness.¶7

- Mean per-patient percentage of positive responses to SEP4 among all intercourse attempts was 57% for CIALIS 20 mg (n=1119) vs 19% for placebo (n=625), P<0.0017
- Successful intercourse (SEP3) rates of 70% and 58% with CIALIS 20 mg (n=253) and CIALIS 10 mg (n=311), respectively, vs placebo 31% (n=300), P<0.001†† ‡‡ 8
- ¶Retrospective analysis of 11 randomized, 12-week, double-blind, placebo-controlled studies.
- #Mean per-patient satisfaction calculated across those attempts during treatment for which the patient achieved successful intercourse. All patients with at least one successful intercourse attempt during treatment, as measured by a "yes" response to SEP3, were included in this analysis.
- ††Results from 5 randomized, 12-week, double-blind, placebo-controlled studies. In the US Academic Centers Study, successful intercourse rates with CIALIS 20 mg (n=146) of 50% vs 25% with placebo (n=49), P<0.001.
- ‡‡Rates based on mean per-patient intercourse success.
CIALIS gives men with comorbid conditions powerful efficacy

- SEP3 data: Patients with diabetes, hypertension, cardiovascular disease, or benign prostatic hyperplasia had significantly higher successful intercourse rates with CIALIS 20 mg (55%, 63%, 70%, and 65%, respectively) than with placebo (23%, 28%, 34%, and 30%, respectively), P<0.0019
- The following groups of patients were excluded from clinical trials: those with MI within the last 90 days; unstable angina or angina during sexual intercourse; stroke or heart failure within the last 6 months; uncontrolled arrhythmia; hypotension; uncontrolled hypertension; and hereditary degenerative retinal disorders4
- §§Retrospective analysis of 11 integrated, 12-week, randomized, double-blind, placebo-controlled trials of 2102 patients with comorbid conditions receiving placebo (n=638), CIALIS 10 mg (n=321), and CIALIS 20 mg (n=1143). Patients with multiple comorbid conditions may have been included in more than one category. Rates based on mean per-patient intercourse success.
For important safety information about CIALIS, click here.
- Data on file. Eli Lilly and Company CIA20051130A.
- Rosen RC, Padma-Nathan H, Shabsigh R, et al. Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20 mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study. J Sex Med. 2004;1:193-200.
- Brock GB, McMahon CG, Chen KK, et al. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol. 2002;168(4 pt 1):1332-1336.
- Cialis [package insert]. Indianapolis, Ind: Eli Lilly and Company; February 2008.
- Young JM, Feldman RA, Auerbach SM, et al. Tadalafil improved erectile dysfunction at twenty-four and thirty-six hours after dosing in men with erectile dysfunction: US Trial. J Androl. 2005;26:310-318.
- Data on file. Eli Lilly and Company CIA20050729D.
- Porst H, Wylie K, Colpi GM, et al. Satisfaction with the hardness of erection and with the overall sexual experience in patients treated with tadalafil. Presented at: 7th Congress of the European Society for Sexual Medicine; December 5-8, 2004. London, England. Poster 164.
- Data on file. Eli Lilly and Company CIA20050912D.
- Lewis RW, Sadovsky R, Eardley I, et al. The efficacy of tadalafil in clinical populations. J Sex Med. 2005;2:517-531.
- Carson CC, Rajfer J, Eardley I, et al. The efficacy and safey of tadalafil: an update. BJU Int. 2004;93:1276-1281.











