A Study in Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Placebo; Tadalafil
Intervention description: One tablet orally daily; Orally once daily
Intervention MeSH terms: Tadalafil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 372.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Erectile Dysfunction

Summary:

      The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed
      once-a-day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and at least 18 years old, with at least a 3-month history of erectile
             dysfunction (ED).

          -  Anticipate having same adult female sexual partner during the study.

          -  Agree to make at least 4 sexual intercourse attempts with the female partner during
             the 4-week run-in phase without medication.

          -  Agree to make at least 1 sexual intercourse attempt per day with the female partner
             during days 1-4 following randomization (with a minimum of three attempts required
             during that period). Also agree to make at least 3 intercourse attempts during days
             5-14 following randomization.

          -  Agree not to use any other ED treatment during the study and for 24 hours after the
             final study visit.

        Partner Inclusion Criteria:

          -  Female and at least 18 years old.

          -  Agree to make at least 4 sexual intercourse attempts with the male sexual study
             partner during the 4-week run-in phase without medication.

          -  Agree to make at least 1 sexual intercourse attempt per day with the male partner
             during days 1-4 following randomization

          -  Agree to make at least 3 intercourse attempts during days 5-14 following
             randomization.

        Exclusion Criteria:

          -  Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5)
             inhibitor on a daily basis for once daily use.

          -  ED caused by other primary sexual disorders, or untreated or inadequately treated
             endocrine disease.

          -  History of radical prostatectomy, other pelvic surgery or penile implant.

          -  Clinically significant penile deformity in the opinion of the investigator.

          -  Clinically significant renal insufficiency, or hepatobiliary disease as determined by
             the investigator.

          -  Glycosylated hemoglobin of >11%.

          -  Present with chronic stable angina treated with long-acting nitrates, or with chronic
             stable angina requiring short-acting nitrates in the last 90 days, or with angina
             occurring during sexual intercourse in the last 6 months.

          -  Have any significant cardiac conditions as described in the protocol exclusion
             criteria.

          -  Have a history of significant central nervous system injuries within the last 6
             months.

          -  Have a history of Human Immunodeficiency Virus infection.

          -  Have any condition that would interfere with the subject's ability to provide informed
             consent or comply with study instructions, would place subject at increased risk, or
             might confound the interpretation of the study results.

          -  Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
             (except finasteride taken as Propecia or Proscar, or Avodart [dutasteride]).

          -  History of drug, alcohol, or substance abuse within the past 6 months, as assessed by
             the investigator.

          -  Previously completed or withdrawn from any other study investigating tadalafil for
             once daily use.

          -  Received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Prior ineffective treatment with any PDE5 inhibitor in the opinion of the
             investigator.