The population was 86% White, 6% Black, 6% Hispanic,
and 2% of other ethnicities,
Study A was conducted primarily in academic centers. Study B was conducted primarily in community-based urology practices. In each of these 2 trials, CIALIS 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables ( see Table 11). The treatment effect ofCIALIS did not diminish over time. Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the TwoPrimary US Trials 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).
The population was 76% White, 1% Black, 3% Hispanic, and 20% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (90%)patients reported ED of at least 1-year duration. In these 5 trials, CIALIS 5, 10, and 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables ( see Tables 12 , 13 and 14). The treatment effect of CIALIS did not diminish over time. Table 12: Mean Endpoint and Change from Baseline for the EF Domain of the IIEF in the General EDPopulation 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 TrialsOutside 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 CIALIS, compared to patients on placebo.
Therefore, in all 7 primary efficacy and safety studies, CIALIS showed statistically significant improvement inpatients' 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. CIALIS was shown to be effective in treating ED inpatients with diabetes mellitus. Patients with diabetes were included in all 7 primary efficacy studies in the general ED population (N=235) and in one study that specifically assessed CIALIS in ED patients with type 1or type 2 diabetes (N=216). In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective cialis 20 mg 8 tablets trial, CIALIS 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 SEPdiary ( see Table 15). Table 15: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in EDPatients with Diabetes CIALIS was shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy. and included patients with ED
of various severities, etiologies
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 20mg | 120 + 8 Pills | 188.15€ 179.19€ | |
| Cialis Original | 20mg | 12 Pills | 78.32€ 74.59€ | |
| Cialis Super Active | 20mg | 90 + 10 Pills | 314.14€ 299.18€ | |
| Cialis Original | 20mg | 22 + 2 Pills | 129.20€ 123.05€ | |
| Cialis Generic | 60mg | 10 Pills | 41.22€ 39.26€ | |
| Cialis Soft Tabs | 20mg | 180 + 8 Pills | 353.17€ 336.35€ | |
| Cialis Generic | 10mg | 10 Pills | 31.41€ 29.91€ | |
| Cialis Original | 20mg | 120 + 8 Pills | 497.29€ 473.61€ | |
| Cialis Generic | 20mg | 90 + 6 Pills | 154.71€ 147.34€ | |
| Cialis Professional | 40mg | 30 Pills | 148.94€ 141.85€ | |
| Cialis Generic | 10mg | 360 + 10 Pills | 388.49€ 369.99€ | |
| Cialis Professional | 40mg | 180 + 4 Pills | 618.23€ 588.79€ | |
| Cialis Black | 80mg | 180 + 10 Pills | 356.64€ 339.66€ | |
| Cialis Original | 20mg | 14 + 2 Pills | 95.75€ 91.19€ | |
| Cialis Generic | 5mg | 270 + 10 Pills | 205.81€ 196.01€ | |
| Cialis Black | 80mg | 360 + 20 Pills | 639.78€ 609.31€ | |
| Cialis Generic | 2.5mg | 30 + 4 Pills | 51.95€ 49.48€ |
(organic, psychogenic, mixed), and with
| Benefit | Description | Evidence Level |
|---|---|---|
| Improved Erectile Function | Consistent daily use can help maintain erectile stability | Moderate |
| Increased Spontaneity | Reduced planning for medication enhances spontaneity | Moderate |
| Better Confidence | Steady performance may boost confidence | Anecdotal |
| Long-term Health Benefits | Possible cardiovascular benefits with regular use | Limited |
multiple co-morbid conditions, including diabetes
mellitus, hypertension, andother cardiovascular disease.
At the 24-hour timepoint, the mean, per patient percentage of attempts resulting in successful intercourse were 42, 56, and 67% for the placebo, CIALIS 10-, and 20-mg groups, respectively. At the 36-hour timepoint, the mean, per-patient percentage of attempts resulting in successful intercourse were 33, 56, and 62% for placebo, CIALIS 10-, and20-mg groups, respectively. The efficacy and safety of CIALIS for once daily use in the treatment of erectile dysfunction has been evaluate din 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853patients. CIALIS, when taken once daily, was cialis pastile shown to be effective in improving erectile function in men with erectile dysfunction (ED). CIALIS was 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.One of these studies was conducted in the United States and one was conducted in centers outside the US.
An additional efficacy and safety study was performed in ED patients with diabetes mellitus. CIALIS was taken once daily at doses ranging from 2.5 to 10 mg. Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took Cialis. 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
| Dosage | Recommended Frequency | Onset Time | Duration of Effect |
|---|---|---|---|
| 2.5 mg | Once daily | 30-60 min | Up to 36 hours |
| 5 mg | Once daily | 30-60 min | Up to 36 hours |
| 10 mg (Less common) | As prescribed (sometimes daily) | 30 min | Varies |
| 20 mg (Not for daily) | As needed, not daily | 30-60 min | Up to 4-6 hours |
of at least 1-year duration.
In 1 randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial in this population (N=303), CIALISdemonstrated 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 inPatients who Developed ED Following Bilateral Nerve-Sparing Radical Prostatectomy Several studies were conducted with the objective of determining the optimal use of CIALIS in the treatment of ED. In one of these studies, the percentage of patients reporting successful erections within 30 minutes of dosing was determined. In this randomized, placebo-controlled, double-blinded trial, 223 patients were randomized to placebo, CIALIS 10, or20 mg. Using a stopwatch, patients recorded the time following dosing at which a successful erection was obtained.
A successful erection was defined as at least 1 erection in 4 attempts that led to successful intercourse.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 CIALIS at a given timepoint after dosing, specifically at24 hours and at 36 hours after dosing. In the first of these studies, 348 patients with ED were randomized to placebo or CIALIS 20 mg. Patients were encouraged to make 4 total attempts at intercourse; 2 attempts were to occur at 24 hours after dosing and 2completely separate attempts were to occur at 36 hours after dosing. The results demonstrated a difference between the placebo group and the CIALIS group at each of the pre-specified timepoints.
At the 24-hourtimepoint, (more specifically, 22 to 26 hours), 53/144 (37%) patients reported at least 1 successful intercourse in the placebo group versus 84/138 (61%) in the CIALIS 20-mg group. 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 CIALIS 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, CIALIS 10, or 20 mg) that were instructed to attempt intercourse at 2 different times(24 and 36 hours post-dosing). Patients were encouraged to make 4 separate attempts at their assigned dose and assigned timepoint. In this study, the results demonstrated a statistically significant difference between the placebo group and the CIALIS groups at each of the pre-specified timepoints.