A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: tadalafil once a day [T(OaD)]; sildenafil citrate as needed [S(PRN)]; tadalafil as needed [T(PRN)]
Intervention description: 5 mg tablet taken once a day (OaD) by mouth for 8 weeks; 100 mg tablet taken as needed (PRN) by mouth for 8 weeks; 20 mg tablet taken as needed (PRN) by mouth for 8 weeks
Intervention MeSH terms: Sildenafil Citrate; Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 378.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to help answer whether tadalafil taken once a day can
      help improve the psychological outcomes (such as sexual self confidence, spontaneity and time
      concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of erectile dysfunction (ED).

          -  Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for
             a period of at least 6 months and expect frequent use (at least one dose per week, on
             average) when administered as needed.

          -  Have never used tadalafil 5 mg or 2.5 mg once a day therapy.

          -  Anticipate having the same adult female sexual partner willing to participate during
             the study.

          -  Agree to make at least four sexual intercourse attempts during the first four weeks of
             the study.

          -  Agree not to use any other treatment for ED (even herbal treatments) during the study.

          -  Agree to follow the directions given by the study doctor and staff about using the
             study drug.

        Exclusion Criteria:

          -  Have any other primary sexual disorders present or penile deformity.

          -  Have history of radical prostatectomy or penile implant.

          -  Have problems with your kidneys, liver, or nervous system.

          -  Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater
             than a value of 11%.

          -  Are being treated for heart disease with any drug that is called a nitrate (for
             example, nitroglycerin).

          -  Have chest pain (called unstable angina or angina) that requires treatment.

          -  Have heart disease that causes symptoms after you exert yourself.

          -  Have had any of the following in the past 90 days: Heart attack, also known as a
             myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft
             surgery); Had a procedure to open up blood vessels in the heart known as angioplasty
             or stent placement (percutaneous coronary intervention).

          -  Have a history of loss of vision in one eye because of nonarteritic anterior ischemic
             optic neuropathy (NAION).

          -  Have retinitis pigmentosa.

          -  Have history of human immunodeficiency virus (HIV).

          -  Have very high or very low blood pressure (your study doctor will discuss the limits
             with you).

          -  Have had a stroke or a significant injury to your brain or spinal cord within the last
             6 months.

          -  Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
             glucose-galactose malabsorption Lactose intolerance.

          -  Have a scheduled or planned surgery requiring anaesthesia during the course of the
             study.

          -  Have a scheduled cataract surgery during the curse of the study.