Tadalafil (Page 10 of 12)

14.4 Tadalafil Tablet 5 mg for Once Daily Use for ED and BPH

The efficacy and safety of tadalafil tablet 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 tadalafil tablet 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 tadalafil tablets.
The efficacy results for patients with both ED and BPH, who received either tadalafil tablet 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.
Tadalafil tablet 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil tablet 5 mg for once daily use also resulted in statistically significant improvement in SEP3. Tadalafil tablets 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 Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPH

Placebo Tadalafil Tablet 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 <0.001
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 <0.001

Table 22: Mean SEP Question 3 Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPH

Placebo Tadalafil Tablet 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%<0.001

Tadalafil tablet 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)


In this study, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 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

Tadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.

NDC Number Size

46708-177-15 30 Tablets (2 blisters of 15 tablets)

Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side.

NDC Number Size

46708-178-30 bottle of 30 Tablets

46708-178-15 30 Tablets (2 blisters of 15 tablets)

Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side.

NDC Number Size

46708-179-30 bottle of 30 Tablets

Tadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side.

NDC Number Size

46708-180-30 bottle of 30 Tablets

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