a study of ly900010 in erectile dysfunction

Conditions: Erectile Dysfunction

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