Cialis Clinical Trials

Cialis has been tested in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. The results revealed that a single dose in a day improved erectile function in men.

Design of Study
aa Cialis was studied in general ED population in 7 random, multi-centered, double-blinded, placebo-controlled , parallel-arm designed of 12 weeks duration. The studies aimed to check the primary efficacy and safety of Tadalafil. Two studies were conducted in United States and five were conducted outside the United States . Additional studies were also conducted involving Ed patients with Diabetes Mellitus and those who undergone prostrate surgery.

In the trials, the patients took a recommended dose ranging from 2.5 to 20 mg , once a day. Patients were free to choose the time interval between dose administration and the time of sexual attempts. Food and alcohol intake were not restricted.

Assessment tools
To asses the effect of Cialis on erectile function , the primary tool was a questionnaire based on Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) and Sexual Encounter Profile ( SEP) .

The IIEF is a 4-week recall questionnaire that was administered at the end of a treatment-free baseline period and subsequently at follow-up visits after randomization. The IIEF EF domain has a 30-point total score, where higher scores reflect better erectile function. SEP is a diary in which patients recorded each sexual attempt made throughout the study. The overall percentage of successful attempts to insert the penis into the vagina and to maintain the erection for successful intercourse is derived for each patient.

Composition of Trial population and Results

• US trials:
  The 2 US trails included a total of 402 men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The population was 78% White, 14% Black, 7% Hispanic, and 1% 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. 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 . The treatment effect of CIALIS did not diminish over time.
• Trials outside US:
  The 5 trials 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 erectile dysfunction 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 erectile function.

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.

Efficacy in ED patients with Diabetes Mellitus
CIALIS was shown to be effective in treating ED in patients with diabetes mellitus.

Efficacy in ED Patients following Radical Prostatectomy

CIALIS was shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy.

Studies to Determine the Optimal Use of CIALIS
In 1 study, the percentage of patients reporting successful erections within 30 minutes of dosing was determined. 223 patients were given Cialis of 10, or 20 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.

The results revealed that Cialis treats impotence 50% faster than Viagra or Levitra.