Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: tadalafil; placebo
Intervention description: 5 milligrams (mg) administered orally once a day for 12 weeks; tablet administered orally once a day for 12 weeks.
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 217.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erectile Dysfunction

Summary:

      The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg
      administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5
      (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on
      tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You are male and aged at least 18 years.

          -  Have a history of erectile dysfunction (ED)(defined as the consistent inability to
             achieve and/or maintain an erection sufficient to permit satisfactory sexual
             intercourse) of at least 3 months duration.

          -  Agree not to use any other treatment for ED, including herbal and over-the-counter
             (OTC) medications, during the study

          -  You agree to make at least four sexual intercourse attempts with the female sexual
             study partner during the 4-week run-in period without medication

          -  Your entry laboratory test results and medical tests meet study requirements

          -  You agree to use the study drug only as instructed by your study doctor and staff and
             to return any unused study drug and containers at the end of the study or as otherwise
             instructed by the study doctor.

          -  If currently using cholesterol lowering medications (for example: statins) or
             medications to lower blood pressure (example: angiotensin-converting enzyme (ACE)
             inhibitors or calcium channel blocker medications), you need to be on a stable dose
             and you and your study doctor do not expect any dose change during the study.

        Exclusion Criteria:

          -  You have received previous or current treatment with tadalafil or any other PDE5
             inhibitor.

          -  Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or
             anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g.
             Avodart®).

          -  You have had significant heart disease as determined by your doctor in charge of this
             study or a member of the doctor's staff.

          -  Have a history of significant central nervous system injuries (including stroke or
             spinal cord injury) within the last 6 months.

          -  Have a history of loss of vision in one eye because of nonarteritic anterior ischemic
             optic neuropathy (NAION), regardless of whether this episode was in connection or not
             with previous PDE5 inhibitor exposure.