A Study of LY900010 in Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: LY2452473; tadalafil; placebo (tadalafil); placebo (LY2452473)
Intervention description: Administered orally, once daily for 12 weeks; Administered orally, once daily for 12 weeks; Administered orally, once daily for 12 weeks; Administered orally, once daily for 12 weeks
Intervention MeSH terms: Tadalafil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 410.0
Sex: Male
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to
      tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED)
      who incompletely respond to tadalafil alone.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Ambulatory men

          -  History of erectile dysfunction of at least 3 months duration

          -  History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at
             the maximum tolerated dose within the label

          -  Anticipate having the same female sexual partner throughout the duration of the study

          -  Are willing and able to make at least 4 sexual intercourse attempts with the female
             sexual partner during each 4-week segment of the study

          -  Agree to use birth control during the study and for 60 days after the study, unless
             the female partner is postmenopausal

          -  Agree not to use any other erectile dysfunction treatment, including herbal treatment,
             during the study and for 96 hours after the last dose of study drug

          -  Screening laboratory tests within normal limits except for testosterone

          -  Without a language barrier, are reliable and willing to follow study procedures

          -  Prostate-specific antigen (PSA) less than 10 nanograms per milliliter (ng/ml). Men
             with PSA greater than 4 and less than 10 ng/ml must have documentation of a negative
             histological biopsy of carcinoma of prostate within 12 months prior to screening

        Exclusion Criteria include:

          -  History of penile implant

          -  History of no response to injection therapy for erectile dysfunction

          -  History of radical prostatectomy or other pelvic surgery with subsequent failure to
             achieve any erection

          -  Exhibit the presence of clinically significant penile deformity in the opinion of the
             investigator

          -  History of prior sexual legal convictions

          -  Bilateral hip replacements

          -  History of cancer within the previous 5 years, except for excised superficial lesions
             such as basal cell carcinoma and squamous cell carcinoma of the skin

          -  Chronic stable angina currently treated with long-acting nitrates

          -  Chronic stable angina requiring treatment with short-acting nitrates within 90 days
             prior to screening

          -  Angina occurring during sexual intercourse in the 6 months prior to screening

          -  Unstable angina within 6 months prior to screening

          -  Myocardial infarction or coronary artery bypass graft surgery within 90 days prior to
             screening

          -  Angioplasty or stent placement within 90 days prior to screening

          -  Congestive heart failure within 6 months prior to screening

          -  History of sudden cardiac arrest

          -  Supraventricular arrhythmia with an uncontrolled ventricular response at rest, or any
             history of spontaneous or induced sustained ventricular tachycardia, or use an
             automatic internal cardioverter-defibrillator

          -  An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the
             investigator places the subject in an unacceptable risk for study participation

          -  Systolic blood pressure greater than 170 or less than 90 millimeters of mercury (mm
             Hg) or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening

          -  Hepatic, renal, human immunodeficiency virus (HIV), or clinically significant active
             neuropsychiatric disease

          -  History of central nervous system injuries (including stroke or spinal cord injury)
             within 6 months prior to screening

          -  Alcohol intake of 5 units or greater per day (1 unit = 12 ounces beer, 5 ounces wine,
             or 1.5 ounces of 80-proof distilled spirits)

          -  Receiving treatment with antiandrogens or 5-alpha reductase inhibitor

          -  Anabolic steroids, calcitonin, oral bisphosphonates, Vitamin D greater than 50,000
             international units per week (IU/week), dehydroepiandrosterone (DHEA), steroidal
             supplements, nutritional products intended to have weight reduction or performance
             enhancing effects, herbal supplements within 7 days prior to screening

          -  Currently treated with a potent cytochrome P450 (CYP) 3A4 inhibitor, such as systemic
             ketoconazole or ritonavir, or a CYP3A4 inducer such as rifampicin