Cialis (Page 10 of 11)

14.4 CIALIS 5 mg for Once Daily Use for ED and BPH

The efficacy and safety of CIALIS for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either CIALIS 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.

In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took CIALIS.

The efficacy results for patients with both ED and BPH, who received either CIALIS 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.

CIALIS 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. CIALIS 5 mg for once daily use also resulted in statistically significant improvement in SEP3. CIALIS 2.5 mg did not result in statistically significant improvement in the total IPSS.

Table 21: Mean IPSS and IIEF EF Domain Changes in the CIALIS 5 mg for Once Daily Use Study in Patients with ED and BPH
Placebo CIALIS 5 mg p-value
Total Symptom Score (IPSS)
(N=193) (N=206)
Baseline 18.2 18.5
Change from Baseline to Week 12 -3.8 -6.1 <.001
EF Domain Score (IIEF EF)
(N=188) (N=202)
Baseline 15.6 16.5
Endpoint 17.6 22.9
Change from Baseline to Week 12 1.9 6.5 <.001
Table 22: Mean SEP Question 3 Changes in the CIALIS 5 mg for Once Daily Use Study in Patients with ED and BPH
Placebo CIALIS 5 mg
(N=187) (N=199) p-value
Maintenance of Erection (SEP3)
Baseline 36% 43%
Endpoint 48% 72%
Change from Baseline to Week 12 12% 32% <.001

CIALIS for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8).

Figure 8
(click image for full-size original)

Figure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L

In this study, the effect of CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (CIALIS 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

CIALIS (tadalafil) is supplied as follows:

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

2.5 mg tablets debossed with “C 2 1/2”
Blisters of 2 x 15 NDC 0002-4465-34
5 mg tablets debossed with “C 5”
Bottles of 30 NDC 0002-4462-30
Blisters of 2 x 15 NDC 0002-4462-34
10 mg tablets debossed with “C 10”
Bottles of 30 NDC 0002-4463-30
20 mg tablets debossed with “C 20”
Bottles of 30 NDC 0002-4464-30

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