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The second study (Study K) randomized 325 patients to receive either tadalafil tablets 5 mg for once daily use or placebo. The full study population was 87% White, 2% Black, 11% other races; 15% was of Hispanic ethnicity.

• Use caution when operating vehicles after taking tadalafil.
• Report any persistent side effects to your healthcare provider.
• Tadalafil 5mg is not intended for use in women.

Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil tablets for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity. Maximum urinary flow rate (Qmax), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K.The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil tablets 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.In each of these 2 trials, tadalafil tablets 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil Tablets for Once Daily Use StudiesFigure 5: Mean IPSS Changes in BPH Patients by Visit in Study JFigure 6: Mean IPSS Changes in BPH Patients by Visit in Study KIn Study J, the effect of tadalafil tablets 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablets 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.In Study K, the effect of tadalafil tablets 5 mg once daily on Qmax was evaluated as a safety endpoint.

• The medication can be taken with or without food.
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Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablets 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups.Efficacy Results in Patients with BPH initiating Tadalafil Tablets and Finasteride – Tadalafil tablets for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (>30 cc) for up to 26 weeks. This additional double-blinded, parallel-design study of 26 weeks duration randomized 696 men to initiate either tadalafil tablets 5 mg with finasteride 5 mg or placebo with tadalafil 10mg daily finasteride 5 mg. The study population had a mean age of 64 years (range 46-86).

Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included.Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). Key secondary endpoints demonstrated improvement in total IPSS starting at the first scheduled observation at week 4 (tadalafil tablets -4.0, placebo -2.3: p<.001) and the score remained decreased through 26 weeks (tadalafil tablets -5.5, placebo -4.5; p=.022). However, the magnitude of the treatment difference between placebo/finasteride and tadalafil tablets/finasteride decreased from 1.7 points at Week 4 to 1.0 point at Week 26, as shown in Table 20 and in Figure 7. The incremental benefit of tadalafil tablets beyond 26 weeks is unknown.Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablets for Once Daily Use Study Together with FinasterideFigure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil Tablets for Once Daily Use Together With FinasterideIn the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire.

8.3 Females and Males of Reproductive Potential

The second study (Study K) randomized 325 patients to receive either tadalafil tablets 5 mg for once daily use or placebo. The full study population was 87% White, 2% Black, 11% other races; 15% was of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil tablets for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity. Maximum urinary flow rate (Qmax), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K.The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil tablets 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.In each of these 2 trials, tadalafil tablets 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo.

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Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil Tablets for Once Daily Use StudiesFigure 5: Mean IPSS Changes in BPH Patients by Visit in Study JFigure 6: Mean IPSS Changes in BPH Patients by Visit in Study KIn Study J, the effect of tadalafil tablets 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablets 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.In Study K, the effect of tadalafil tablets 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 tablets 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups.Efficacy Results in Patients with BPH initiating Tadalafil Tablets and Finasteride – Tadalafil tablets for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (>30 cc) for up to 26 weeks. This additional double-blinded, parallel-design study of 26 weeks duration randomized 696 men to initiate either tadalafil tablets 5 mg with finasteride 5 mg or placebo with tadalafil 10mg daily finasteride 5 mg. The study population had a mean age of 64 years (range 46-86). Tadalafil tablets with finasteride (N=203) was compared to placebo with finasteride (N=201).

A statistically significant improvement from baseline (tadalafil tablets/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.0; p<.001).14.4 Tadalafil Tablets 5 mg for Once Daily Use for ED and BPHThe efficacy and safety of tadalafil tablets 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 tablets 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.

5.8 Hepatic Impairment

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.

2.5 Use with Food

Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included.Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). Key secondary endpoints demonstrated improvement in total IPSS starting at the first scheduled observation at week 4 (tadalafil tablets -4.0, placebo -2.3: p<.001) and the score remained decreased through 26 weeks (tadalafil tablets -5.5, placebo -4.5; p=.022). However, the magnitude of the treatment difference between placebo/finasteride and tadalafil tablets/finasteride decreased from 1.7 points at Week 4 to 1.0 point at Week 26, as shown in Table 20 and in Figure 7. The incremental benefit of tadalafil tablets beyond 26 weeks is unknown.Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablets for Once Daily Use Study Together with FinasterideFigure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil Tablets for Once Daily Use Together With FinasterideIn the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. Tadalafil tablets with finasteride (N=203) was compared to placebo with finasteride (N=201).

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A statistically significant improvement from baseline (tadalafil tablets/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.0; p<.001).14.4 Tadalafil Tablets 5 mg for Once Daily Use for ED and BPHThe efficacy and safety of tadalafil tablets 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 tablets 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). 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 tablets 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.Tadalafil tablets 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 tadalafil 40mg tablets 5 mg for once daily use also resulted in statistically significant improvement in SEP3.

What is erectile dysfunction (ED)?

What should I know about tadalafil before using it?

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 Tablets 5 mg for Once Daily Use Study in Patients with ED and BPHTable 22: Mean SEP Question 3 Changes in the Tadalafil Tablets 5 mg for Once Daily Use Study in Patients with ED and BPHTadalafil 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 LIn this study, the effect of tadalafil tablets 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 tablets 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.

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Several assessment tools were used to evaluate the effect of tadalafil tablets on erectile function. SEP Question 2 asks, “Were you able to insert your penis into the partner’s vagina?” SEP Question 3 asks, “Did your erection last long enough for you to have successful intercourse?” The overall percentage of successful attempts to insert the penis into the vagina (SEP2) and to maintain the erection for successful intercourse (SEP3) is derived for each patient. Results in ED Population in US Trials — The 2 primary US efficacy and safety trials included a total of 402 men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The treatment effect of tadalafil tablets did not diminish over time. Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Primary US Trials Results in General ED Population in Trials Outside the US — The 5 primary efficacy and safety studies conducted in the general ED population outside the US included 1112 patients, with a mean age of 59 years (range 21 to 82 years).

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Table 12: Mean Endpoint and Change from Baseline for the EF Domain of the IIEF in the General ED Population in Five Primary Trials Outside the US Table 13: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 2 (“Were you able to insert your penis into the partner’s vagina?”) in the General ED Population in Five Pivotal Trials Outside the US Table 14: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 3 (“Did your erection last long enough for you to have successful intercourse?”) in the General ED Population in Five Pivotal Trials Outside the US In addition, there were improvements in EF domain scores, success rates based upon SEP Questions 2 and 3, and patient-reported improvement in erections across patients with ED of all degrees of disease severity while taking tadalafil tablets, compared to patients on placebo. The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. Tadalafil tablets, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). Tadalafil tablets were studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Additional efficacy and safety studies were performed in ED patients with buy tadalafil diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy. In these 7 trials, tadalafil tablets were taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. Food and alcohol intake were not restricted. Several assessment tools were used to evaluate the effect of tadalafil tablets on erectile function. SEP Question 2 asks, “Were you able to insert your penis into the partner’s vagina?” SEP Question 3 asks, “Did your erection last long enough for you to have successful intercourse?” The overall percentage of successful attempts to insert the penis into the vagina (SEP2) and to maintain the erection for successful intercourse (SEP3) is derived for each patient.

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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 tablets 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.Tadalafil tablets 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 tadalafil 40mg tablets 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 Tablets 5 mg for Once Daily Use Study in Patients with ED and BPHTable 22: Mean SEP Question 3 Changes in the Tadalafil Tablets 5 mg for Once Daily Use Study in Patients with ED and BPHTadalafil 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 LIn this study, the effect of tadalafil tablets 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 tablets 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups. The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients.

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Tadalafil tablets, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). Tadalafil tablets were studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Additional efficacy and safety studies were performed in ED patients with buy tadalafil diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy. In these 7 trials, tadalafil tablets were taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. Food and alcohol intake were not restricted. Results in ED Population in US Trials — The 2 primary US efficacy and safety trials included a total of 402 men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The treatment effect of tadalafil tablets did not diminish over time. Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Primary US Trials Results in General ED Population in Trials Outside the US — The 5 primary efficacy and safety studies conducted in the general ED population outside the US included 1112 patients, with a mean age of 59 years (range 21 to 82 years). Table 12: Mean Endpoint and Change from Baseline for the EF Domain of the IIEF in the General ED Population in Five Primary Trials Outside the US Table 13: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 2 (“Were you able to insert your penis into the partner’s vagina?”) in the General ED Population in Five Pivotal Trials Outside the US Table 14: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 3 (“Did your erection last long enough for you to have successful intercourse?”) in the General ED Population in Five Pivotal Trials Outside the US In addition, there were improvements in EF domain scores, success rates based upon SEP Questions 2 and 3, and patient-reported improvement in erections across patients with ED of all degrees of disease severity while taking tadalafil tablets, compared to patients on placebo.