Cialis Clinical Trials and Studies
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Cialis Clinical Trials and Studies
Two Cialis clinical studies were conducted in 571 patients in an at-home setting to define the period of responsiveness to Cialis (tadalafil). Cialis (tadalafil) demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients' ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing. Sexual Encounter Profile (SEP) diary data collected in Clialis clinical studies supports this period of responsiveness. In these studies patients were free to choose the time interval between Cialis dose administration and the time of sexual attempts.
Cialis (tadalafil) administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate. When Cialis (tadalafil) and certain oral antihypertensive medications were assessed in medicine interaction studies, Cialis (tadalafil) did not result in clinically significant augmentation of the antihypertensive effects of those medications.
In a study to assess the effects of Cialis (tadalafil) on vision, no impairment of colour discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test. This finding is consistent with the low affinity of Cialis (tadalafil) for PDE6 compared to PDE5. In addition, no effects were observed on visual acuity, electroretinograms, intraocular pressure, or pupillometry. Across all Clialis clinical studies, reports of changes in colour vision were rare (< 0.1%).
Cialis had no clinically relevant effects on sperm concentration, sperm count, motility, or morphology in 103 men in a study of daily doses of 10 mg for 6 months or 111 men in a study of daily doses of 20 mg for 6 months. Cialis (tadalafil) at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), aetiologies, ages (range 21-86 years), and ethnicities. Most patients reported erectile dysfunction of at least 1 year in duration. In the primary efficacy studies of general populations, 81% of patients reported that Cialis (tadalafil) improved their erections. Also, patients with erectile dysfunction in all severity categories reported improved erections while taking Cialis (tadalafil) (86%, 83% and 72% for mild, moderate, and severe, respectively). In the primary efficacy studies, 75% of intercourse attempts were successful in Cialis (tadalafil)-treated patients.
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