Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy.In these 7 trials, CIALIS was taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day.
| Attribute | Description | Notes |
|---|---|---|
| Generic Name | Tadalafil | Main active ingredient |
| Brand Name | Cialis (by Lilly) | Commercial name |
| Dosage Forms | Tablets, oral | Available forms |
| Typical Dose | 5 mg, 10 mg, 20 mg | Varies per prescription |
| Onset of Action | 30-60 minutes | Time to effect |
| Duration of Effect | Up to 36 hours | Pharmacological window |
Food and alcohol intake were not restricted.Several assessment tools were used to evaluate the effect of CIALIS 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 CIALIS did not diminish over time.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).
2.5 Use with Food
17.8 Sudden Hearing Loss
How does tadalafil work (mechanism of action)?
The treatment effect of CIALIS did not diminish over time.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 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 — CIALIS was shown to be effective in treating ED in patients with diabetes mellitus. In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective 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 SEP diary (see Table 15).Efficacy Results in ED Patients following Radical Prostatectomy — CIALIS was 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), 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 SEP diary (see Table 16).Results in Studies to Determine the Optimal Use of CIALIS — Several studies were conducted with the objective of determining the optimal use of CIALIS 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 CIALIS 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 CIALIS 20 mg. 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).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 10mg | 270 + 10 Pills | 308.71€ 294.01€ | |
| Cialis Generic | 20mg | 90 + 6 Pills | 154.71€ 147.34€ | |
| Cialis Generic | 5mg | 30 + 4 Pills | 53.56€ 51.01€ | |
| Cialis Professional | 20mg | 180 + 4 Pills | 423.11€ 402.96€ | |
| Cialis Generic | 2.5mg | 10 Pills | 28.51€ 27.15€ | |
| Cialis Generic | 2.5mg | 60 + 4 Pills | 83.43€ 79.46€ | |
| Cialis Generic | 40mg | 30 + 4 Pills | 74.97€ 71.40€ | |
| Cialis Original | 20mg | 120 + 8 Pills | 497.29€ 473.61€ | |
| Cialis Generic | 60mg | 90 + 6 Pills | 196.67€ 187.30€ | |
| Cialis Professional | 40mg | 270 + 6 Pills | 898.37€ 855.59€ | |
| Cialis Original | 20mg | 12 Pills | 78.32€ 74.59€ | |
| Cialis Super Active | 20mg | 20 + 4 Pills | 92.35€ 87.95€ | |
| Cialis Generic | 10mg | 10 Pills | 31.41€ 29.91€ | |
| Cialis Generic | 60mg | 30 + 2 Pills | 85.33€ 81.27€ | |
| Cialis Super Active | 20mg | 270 + 30 Pills | 661.49€ 629.99€ | |
| Cialis Soft Tabs | 20mg | 90 + 6 Pills | 216.71€ 206.39€ | |
| Cialis Professional | 40mg | 90 + 2 Pills | 348.59€ 331.99€ |
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-, and 20-mg groups, respectively.14.2 CIALIS for Once Daily Use for EDThe efficacy and safety of CIALIS 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.
5. Warnings and Precautions
Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy.In these 7 trials, CIALIS was 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 CIALIS 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 CIALIS did not diminish over time.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). The treatment effect of CIALIS did not diminish over time.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 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 — CIALIS was shown to be effective in treating ED in patients with diabetes mellitus.
8.6 Hepatic Impairment
In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective 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 SEP diary (see Table 15).Efficacy Results in ED Patients following Radical Prostatectomy — CIALIS was 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), 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 SEP diary (see Table 16).Results in Studies to Determine the Optimal Use of CIALIS — Several studies were conducted with the objective of determining the optimal use of CIALIS 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 CIALIS 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 CIALIS 20 mg. 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). 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-, and 20-mg groups, respectively.14.2 CIALIS for Once Daily Use for EDThe efficacy and safety of CIALIS 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.
7.2 Potential for Other Drugs to Affect CIALIS
CIALIS, when taken once daily, was 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. Timing of sexual activity was not restricted relative to when patients took Cialis.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, 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 SEP diary (see Table 17). When taken as directed, CIALIS was effective at improving erectile function.In the 6 month double-blind study, the treatment effect of CIALIS did not diminish over time.Efficacy Results in ED Patients with Diabetes Mellitus — CIALIS for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. CIALIS, when taken once daily, was 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.
2.2 CIALIS for Once Daily Use for Erectile Dysfunction
In this third 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 SEP diary (see Table 18).14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)The efficacy and safety of CIALIS for once daily use for the treatment of the signs and symptoms of BPH was buy cialis 5mg 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 CIALIS 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 CIALIS 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, CIALIS 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.In Study J, the effect of CIALIS 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 (CIALIS 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 CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint.
6.1 Clinical Trials Experience
Mean Qmax increased from baseline in both the treatment and placebo groups (CIALIS 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 CIALIS and Finasteride – CIALIS 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.CIALIS 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 CIALIS beyond 26 weeks is unknown.Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking CIALIS 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. A statistically significant improvement from baseline (CIALIS/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (CIALIS/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (CIALIS/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (CIALIS/finasteride 4.7, placebo/finasteride 0.0; p<.001).14.4 CIALIS 5 mg for Once Daily Use for ED and BPHThe efficacy and safety of CIALIS 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 CIALIS 2.5 mg, 5 mg, for once daily use or placebo. 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).
17.1 Nitrates
Timing of sexual activity was not restricted relative to when patients took Cialis.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).
- Patient reviews often highlight Cialis’s efficacy and duration.
- The medication is praised for enabling spontaneity in sexual activity.
- Side effects like headache tend to diminish with ongoing use.
- Cialis use requires medical supervision to ensure safety.
- The medication can improve quality of life in men with ED.
- Cialis is part of many men’s long-term health management plans.
- Regular cardiovascular evaluation is important for Cialis users.
- Cialis allows flexibility in managing erectile dysfunction.
- The drug’s development involved collaboration across research centers.
- Lilly maintains a portfolio including other sexual health drugs.
- Cialis use should follow professional medical advice.
- Patient education about Cialis contributes to treatment success.
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).
- Cialis’s discovery resulted from targeted medicinal chemistry efforts.
- Eli Lilly’s investment supported large-scale clinical development.
- The drug was approved after successful phase III trials.
- Cialis changed the standard of care for erectile dysfunction.
- Patient safety and efficacy data have been extensively published.
- The medication is designed for once-daily or as-needed use.
- Clinical guidelines endorse Cialis as a treatment choice.
- Patient satisfaction surveys show positive outcomes.
- Lilly’s Cialis marketing emphasizes science and patient benefits.
- Medication errors are reduced with clear prescribing instructions.
- Cialis requires prescription and proper medical evaluation.
- It remains a key option in the global ED treatment market.
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, 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 SEP diary (see Table 17).
Side Effects
5.5 Sudden Hearing Loss
When taken as directed, CIALIS was effective at improving erectile function.In the 6 month double-blind study, the treatment effect of CIALIS did not diminish over time.Efficacy Results in ED Patients with Diabetes Mellitus — CIALIS for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. In this third 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 SEP diary (see Table 18).14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)The efficacy and safety of CIALIS for once daily use for the treatment of the signs and symptoms of BPH was buy cialis 5mg 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 CIALIS 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 CIALIS 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, CIALIS 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.In Study J, the effect of CIALIS 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 (CIALIS 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 CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (CIALIS 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 CIALIS and Finasteride – CIALIS 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.CIALIS 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).
| Parameter | Value | Details |
|---|---|---|
| Absorption | Rapid, within 30-120 minutes | Food intake can delay absorption |
| Bioavailability | ~40% | Fraction of dose that enters circulation |
| Metabolism | Liver (CYP3A4 enzyme) | Enzymatic processing |
| Half-life | ~17.5 hours | Duration of action in the body |
| Excretion | Feces (~61%), Urine (~36%) | Mainly via hepatic pathways |
The incremental benefit of CIALIS beyond 26 weeks is unknown.Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking CIALIS 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. A statistically significant improvement from baseline (CIALIS/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (CIALIS/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (CIALIS/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (CIALIS/finasteride 4.7, placebo/finasteride 0.0; p<.001).14.4 CIALIS 5 mg for Once Daily Use for ED and BPHThe efficacy and safety of CIALIS 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 CIALIS 2.5 mg, 5 mg, for once daily use or placebo.
| Use Case | Description | Notes |
|---|---|---|
| Erectile Dysfunction (ED) | Improves ability to achieve/maintain erection | Most common use |
| Pulmonary Arterial Hypertension | Reduces blood pressure in lungs | Prescribed under different dose |
| Benign Prostatic Hyperplasia | Relieves urinary symptoms | Off-label use |
| Raynaud's Phenomenon | Relaxes blood vessels | Experimental treatment |
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).
- Cialis has been studied in combination with other ED treatments.
- Research explores effects of Cialis on other vascular diseases.
- The medication’s development highlighted the role of enzyme PDE5.
- Side effect profiles are monitored in post-marketing surveillance.
- Cialis is included in many guidelines as a first-line ED therapy.
- The drug is contraindicated with certain cardiac medications.
- Cost and accessibility remain concerns for some patients.
- Generic versions have improved affordability worldwide.
- Cialis may improve confidence and emotional well-being.
- Ongoing trials explore new indications beyond ED and BPH.
- Patient adherence to therapy is critical for results.
- Lilly’s commitment to sexual health research continues.