Tadalafil (Page 10 of 12)

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

The efficacy and safety of tadalafil 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 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.

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

Tadalafil 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 5 mg for once daily use also resulted in statistically significant improvement in SEP3. Tadalafil 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 5 mg for Once Daily Use Study in Patients with ED and BPH
Placebo Tadalafil 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 5 mg for Once Daily Use Study in Patients with ED and BPH
Placebo Tadalafil 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 tablets 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

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

Tadalafil Tablets
(click image for full-size original)

In this study, the effect of Tadalafil 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 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 white colored, capsule shape, biconvex, film-coated tablets debossed ‘T 1′ on one side and plain on the other side and are supplied as follows:

NDC 68382-896-06 in bottle of 30 tablets

NDC 68382-896-16 in bottle of 90 tablets

NDC 68382-896-01 in bottle of 100 tablets

NDC 68382-896-05 in bottle of 500 tablets

NDC 68382-896-10 in bottle of 1000 tablets

NDC 68382-896-99 in unit-dose blister cartons of 30 (2 x 15) unit-dose tablets

Tadalafil Tablets USP, 5 mg are yellow colored, oval shape, biconvex with bevel edge, film-coated tablets debossed ’897′ on one side and plain on the other side and are supplied as follows:

NDC 68382-897-50 in bottle of 10 tablets

NDC 68382-897-06 in bottle of 30 tablets

NDC 68382-897-16 in bottle of 90 tablets

NDC 68382-897-01 in bottle of 100 tablets

NDC 68382-897-05 in bottle of 500 tablets

NDC 68382-897-10 in bottle of 1000 tablets

NDC 68382-897-99 in unit-dose blister cartons of 30 (2 x 15) unit-dose tablets

Tadalafil Tablets USP, 10 mg are yellow colored, capsule shape, biconvex, film-coated tablets debossed ’898′ on one side and plain on the other side and are supplied as follows:

NDC 68382-898-06 in bottle of 30 tablets

NDC 68382-898-16 in bottle of 90 tablets

NDC 68382-898-01 in bottle of 100 tablets

NDC 68382-898-05 in bottle of 500 tablets

NDC 68382-898-10 in bottle of 1000 tablets

NDC 68382-898-99 in unit-dose blister cartons of 30 (2 x 15) unit-dose tablets

Tadalafil Tablets USP, 20 mg are yellow colored, oval shape, biconvex with bevel edge, film-coated tablets debossed ’899′ on one side and plain on the other side and are supplied as follows:

NDC 68382-899-06 in bottle of 30 tablets

NDC 68382-899-16 in bottle of 90 tablets

NDC 68382-899-01 in bottle of 100 tablets

NDC 68382-899-05 in bottle of 500 tablets

NDC 68382-899-10 in bottle of 1000 tablets

NDC 68382-899-99 in unit-dose blister cartons of 30 (2 x 15) unit-dose tablets

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