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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. Therefore, in all 7 primary efficacy and safety studies, tadalafil tablets showed statistically significant improvement in patients’ ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries. Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil tablets were shown to be effective in treating ED in patients with diabetes mellitus. In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 15). Table 15: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in ED Patients with Diabetes Efficacy Results in ED Patients following Radical Prostatectomy — Tadalafil tablets were shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy. In 1 randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial in this population (N=303), tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 16). Table 16: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in Patients who Developed ED Following Bilateral Nerve-Sparing Radical Prostatectomy Results in Studies to Determine the Optimal Use of Tadalafil Tablets — Several studies were conducted with the objective of determining the optimal use of tadalafil tablets in the treatment of ED. At or prior to 30 minutes, 35% (26/74), 38% (28/74), and 52% (39/75) of patients in the placebo, 10-, and 20-mg groups, respectively, reported successful erections as defined above. Two studies were conducted to assess the efficacy of tadalafil tablets at a given timepoint after dosing, specifically at 24 hours and at 36 hours after dosing.
| Region | Average Price (per tablet) | Availability | Notes |
|---|---|---|---|
| USA | $0.50 - $1.00 | Widely available | Prescription required |
| Europe | €0.40 - €0.90 | Readily available | Over-the-counter in some countries |
| Asia | $0.20 - $0.70 | Easy access | Often cheaper |
| Africa | $0.30 - $1.20 | Varies | Generic options increasing |
| Australia | AUD 1.50 - AUD 3.00 | Prescription only | Higher cost |
In the first of these studies, 348 patients with ED were randomized to placebo or tadalafil tablets 20 mg.
- Tadalafil 5mg may interact with other medications.
- Follow prescribed instructions for safe use.
- Misuse can lead to serious health risks or side effects.
At the 36-hour timepoint (more specifically, 33 to 39 hours), 49/133 (37%) of patients reported at least 1 successful intercourse in the placebo group versus 88/137 (64%) in the tadalafil tablets 20-mg group. In the second of these studies, a total of 483 patients were evenly randomized to 1 of 6 groups: 3 different dosing groups (placebo, tadalafil tablets 10, or 20 mg) that were instructed to attempt intercourse at 2 different times (24 and 36 hours post-dosing).
2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction
Drug Interactions
At the 36-hour timepoint, the mean, per-patient percentage of attempts resulting in successful intercourse were 33, 56, and 62% for placebo, tadalafil tablets 10-, and tadalafil 20mg price 20-mg groups, respectively. The efficacy and safety of tadalafil tablets for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 5mg | 360 + 10 Pills | 268.08€ 255.31€ | |
| Cialis Generic | 60mg | 360 + 10 Pills | 570.52€ 543.35€ | |
| Cialis Generic | 10mg | 360 + 10 Pills | 388.49€ 369.99€ | |
| Cialis Generic | 2.5mg | 90 + 6 Pills | 112.43€ 107.08€ | |
| Cialis Generic | 40mg | 90 + 6 Pills | 171.35€ 163.19€ | |
| Cialis Generic | 40mg | 270 + 10 Pills | 382.19€ 363.99€ | |
| Cialis Generic | 40mg | 30 + 4 Pills | 74.97€ 71.40€ | |
| Cialis Generic | 10mg | 20 Pills | 48.23€ 45.93€ | |
| Cialis Generic | 60mg | 60 + 4 Pills | 145.06€ 138.15€ | |
| Cialis Generic | 60mg | 30 + 2 Pills | 85.33€ 81.27€ |
Tadalafil tablets, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).
What should I know about storage and disposal of this medication?
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 sublingual tadalafil 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 Studies Figure 5: Mean IPSS Changes in BPH Patients by Visit in Study J Figure 6: Mean IPSS Changes in BPH Patients by Visit in Study K In Study J, the effect of tadalafil tablets 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. In Study K, the effect of tadalafil tablets 5 mg once daily on Qmax was evaluated as a safety endpoint.
Sample size
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. 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). The incremental benefit of tadalafil tablets beyond 26 weeks is unknown. Tadalafil tablets were studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-and 24-weeks duration, respectively. Timing of sexual activity was not restricted relative to when patients took tadalafil tablets.
- Tadalafil 5mg has a duration of action up to 36 hours.
- It can improve spontaneous sexual activity.
- Dosage adjustments may be necessary for certain health conditions.
Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). Most (>96%) patients reported ED of at least 1-year duration. The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). Ninety-three percent of patients reported ED of at least 1-year duration. In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17).
| Property | Description | Value/Notes |
|---|---|---|
| Active Ingredient | Tadalafil | 5 mg |
| Drug Class | Phosphodiesterase type 5 inhibitor | - |
| Half-life | 17.5 hours | Approximate |
| Bioavailability | ~80% | Oral administration |
| Absorption Time | 2 hours | Peak plasma concentration |
| Metabolism | Liver (via CYP3A4 enzyme) | - |
| Excretion | Feces (~61%), Urine (~36%) | - |
When taken as directed, tadalafil tablets were effective at improving erectile function. In the 6 month double-blind study, the treatment effect of tadalafil tablets did not diminish over time. Table 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil Tablets for Once Daily Use Studies Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil tablets for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. In this third trial, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by tadalafil 2 5 mg the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18).
12.2 Pharmacodynamics
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. Therefore, in all 7 primary efficacy and safety studies, tadalafil tablets showed statistically significant improvement in patients’ ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries. Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil tablets were shown to be effective in treating ED in patients with diabetes mellitus. In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 15). Table 15: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in ED Patients with Diabetes Efficacy Results in ED Patients following Radical Prostatectomy — Tadalafil tablets were shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy.
Tadalafil strengths
In 1 randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial in this population (N=303), tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 16). Table 16: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in Patients who Developed ED Following Bilateral Nerve-Sparing Radical Prostatectomy Results in Studies to Determine the Optimal Use of Tadalafil Tablets — Several studies were conducted with the objective of determining the optimal use of tadalafil tablets in the treatment of ED. At or prior to 30 minutes, 35% (26/74), 38% (28/74), and 52% (39/75) of patients in the placebo, 10-, and 20-mg groups, respectively, reported successful erections as defined above. Two studies were conducted to assess the efficacy of tadalafil tablets at a given timepoint after dosing, specifically at 24 hours and at 36 hours after dosing. In the first of these studies, 348 patients with ED were randomized to placebo or tadalafil tablets 20 mg. Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil Tablets for Once Daily Use Study in ED Patients with Diabetes The efficacy and safety of tadalafil tablets for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.
Shipping & Delivery
Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablets for Once Daily Use Study Together with Finasteride Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil Tablets for Once Daily Use Together With Finasteride In 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. 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). The 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.
Statistical analysis
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. 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.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
At the 36-hour timepoint (more specifically, 33 to 39 hours), 49/133 (37%) of patients reported at least 1 successful intercourse in the placebo group versus 88/137 (64%) in the tadalafil tablets 20-mg group. In the second of these studies, a total of 483 patients were evenly randomized to 1 of 6 groups: 3 different dosing groups (placebo, tadalafil tablets 10, or 20 mg) that were instructed to attempt intercourse at 2 different times (24 and 36 hours post-dosing). At the 36-hour timepoint, the mean, per-patient percentage of attempts resulting in successful intercourse were 33, 56, and 62% for placebo, tadalafil tablets 10-, and tadalafil 20mg price 20-mg groups, respectively. The efficacy and safety of tadalafil tablets for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients. Tadalafil tablets, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).
Before taking tadalafil,
Tadalafil tablets were studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-and 24-weeks duration, respectively. Timing of sexual activity was not restricted relative to when patients took tadalafil tablets. Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). Most (>96%) patients reported ED of at least 1-year duration. The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). 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 sublingual tadalafil weeks) in Study K and remained decreased through 12 weeks.
Overdose/Missed Dose
Ninety-three percent of patients reported ED of at least 1-year duration. In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17). When taken as directed, tadalafil tablets were effective at improving erectile function. In the 6 month double-blind study, the treatment effect of tadalafil tablets did not diminish over time. Table 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil Tablets for Once Daily Use Studies Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil tablets for once daily use was shown to be effective in treating ED in patients with diabetes mellitus.
What should I know about tadalafil before using it?
In this third trial, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by tadalafil 2 5 mg the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18). Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil Tablets for Once Daily Use Study in ED Patients with Diabetes The efficacy and safety of tadalafil tablets for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. 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. 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. Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil Tablets for Once Daily Use Studies Figure 5: Mean IPSS Changes in BPH Patients by Visit in Study J Figure 6: Mean IPSS Changes in BPH Patients by Visit in Study K In Study J, the effect of tadalafil tablets 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. 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. 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). 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 Finasteride Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil Tablets for Once Daily Use Together With Finasteride In 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. 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). The 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.