A Comparison of Psychosocial Outcomes following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men with Erectile Dysfunction - ND

• Conditions: Ercetile Disfunction; MedDRA version: 9.1Level: LLTClassification code 10025504Term: Male erectile disturbance due to general medical condition

• Registration Number: EUCTR2008-001055-21-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

1.Are male and at least 18 years of age at Visit 1. 2.Are able to read, understand and provide informed consent. 3.Have history of erectile dysfunction (ED) based on the disease diagnostic criteria (Section 4.1.1). 4.Have had satisfactory response (in the opinion of the investigator) to an oral PDE5 inhibitor PRN (tadalafil, sildenafil citrate, or vardenafil HCl) for treatment of ED, for a period of at least 6 months, at an average minimum frequency of 1 dose per week. 5.Anticipate frequent use (at least one dose per week, on average) of PDE5 inhibitors when administered PRN during the study. 6.Have never used tadalafil 5 mg or 2.5 mg once a day therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Present with impotence caused by other primary sexual disorders including premature ejaculation or impotence caused by untreated endocrine disease (for example, hypopituitarism, hypothyroidism, or hypogonadism). 2.Have a history of radical prostatectomy, or other pelvic surgery with subsequent failure to achieve erection. 3.Have a history of penile implant. 4.Have a clinically significant penile deformity (such as Peyronie?s disease) in the opinion of the investigator. 5.Exhibit evidence of clinically significant renal insufficiency as determined by the investigator. 6.Exhibit evidence of active symptomatic hepatobiliary disease, as determined by the investigator. 7.Exhibit Hemoglobin A1c >11% at Visit 1, in subjects with a history of diabetes mellitus of any type. 8.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. 9.Have met the criteria for unstable angina (Protocol Attachment S024.3) within 6 months before Visit 1, or have a history of myocardial infarction or coronary artery bypass graft surgery within 90 days before Visit 1, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days before Visit 1. 10.Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for ≥30 sec) despite medical or device therapy, or use an internal cardioverter-defibrillator. 11.Have a history of sudden cardiac arrest despite medical or device therapy. 12.Exhibit any evidence of congestive heart failure (NYHA Class 2 or above, Protocol Attachment S024.4) within 6 months before Visit 1. 13.Have had a new or significant conduction defect within 90 days before Visit 1. 14.Exhibit systolic blood pressure >170 or <90 mmHg or diastolic blood pressure >100 or <50 mmHg at screening (if stress is suspected, retest under basal conditions), or have a history of malignant hypertension. 15.Have a history of significant central nervous system injuries (including stroke and spinal cord injury) within the last 6 months. 16.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. 17.Have retinitis pigmentosa. 18.Currently receive treatment with nitrates, nonselective alpha [1]-adrenergic blockers (such as doxazosin), cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar or Avodart [dutasteride]).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified