Erectile dysfunction. MedDRA version: 9.1 Level: LLT Classification code 10061461 Term: Erectile dysfunction
Conditions
Interventions
Trade Name: Cialis
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tadalafil
CAS Number: 171596-29-5
Current Sponsor code: LY450190
Other descriptive name: Cialis
Concentration unit: mg m
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male and aged at least 18 years. - Able to read, understand and provide signed informed consent. - Have a history of 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. - Anticipate having the same adult female sexual partner during the study. (If a qualifying participant has more than one female partner during the study the participant will not be excluded from the trial; however the participant will be required to respond to questionnaires based on his sexual interactions with only one of these partners.) - Agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication. (Subjects who do not make at least four sexual attempts during the run-in period will not be enrolled in the study; these subjects will be considered screen failures.) - Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study (Visit 1 through Visit 6). (Subjects who take any of these medications during the 4 week run-in period will not be enrolled in the study; these subjects will be considered screen failures.) - Agree to participate in recording responses to questionnaires and other instruments used in this study. - If currently receiving statins, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers, have been on a stable dose for at least 3 months before Visit 1 with no anticipated change in dose during the study. - If currently receiving calcium channel blocker medication: (a) are currently receiving a once daily regimen of calcium channel blocker at the time of entry to the study (Visit 1), with no anticipated change during the study; or (b) it is considered acceptable to adjust their medication to a once daily formulation during the run-in period, such that they are able and willing to receive a once daily formulation from Visit 2 through Visit 6. 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
Exclusion criteria: - Previous or current treatment with tadalafil or any other PDE5 inhibitor. - Have ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated or inadequately treated endocrine disease (for example, hypopituitarism, hypogonadism, or uncorrected hypothyroidism). The subject may be included if, in the opinion of the investigator, the ED persists after adequate treatment of the underlying endocrine disease. - Have a history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection. - Have a history of penile implant. - Have a clinically significant penile deformity in the opinion of the investigator. - Have communicable skin or sexually transmitted diseases, or have any rash or lesions on the penis or surrounding area. - Exhibit evidence of clinically significant renal insufficiency as determined by the investigator. - Exhibit clinical evidence of severe hepatic impairment at Visit 1. - Exhibit hemoglobin A1c >11% at Visit 1. - 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 met the criteria for unstable angina 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. - 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 seconds), or use an automatic internal cardioverter-defibrillator. - Have a history of sudden cardiac arrest. - Exhibit any evidence of congestive heart failure (New York Heart Association [NYHA] Class II or above) within 6 months before Visit 1. - Have had a new, significant cardiac conduction defect within 90 days before Visit 1. - Exhibit systolic blood pressure >170 or 100 or <50 mmHg at Visits 1 or 2 (if stress is suspected, retest under basal conditions), or have a history of malignant hypertension. - Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months. - Have a history of human immunodeficiency virus (HIV) infection. - Have any condition that, in the opinion of the investigator, would interfere with the subject's ability to provide informed consent or comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results. - Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®). - Have a history of drug, alcohol or substance abuse within the past 6 months, as assessed by the investigator at Visit 1. - Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. - Are Lilly employees. - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of tadalafil 5 mg (with possible down-titration to 2.5 mg) compared with placebo, when taken orally once a day over 12 weeks, in improving erectile function in men with ED who are naïve to PDE5 inhibitors. - To assess the safety of tadalafil 5 mg (with possible down-titration to 2.5 mg) administered once a day compared with placebo in men with ED who are naïve to PDE5 inhibitors. ;Secondary Objective: - To evaluate the efficacy of tadalafil compared with placebo as measured by other variables, including other IIEF domains, other SEP questions, and responses to the Global Assessment Question (GAQ) 1 and 2. - To characterize the endothelium dysfunction profile in men with ED. - To evaluate the effect of tadalafil compared with placebo on endothelial dysfunction in men with ED. - To evaluate the relationship between endothelium dysfunction changes and erectile function changes, assessed by the efficacy measures, including NPT assessments and morning erections changes. - To evaluate the effect of tadalafil compared with placebo on the NPT pattern. - To evaluate the effect of tadalafil compared with placebo on the frequency of spontaneous morning erections. - To evaluate subjects' treatment satisfaction with tadalafil compared with placebo. - To evaluate psychosocial outcomes of tadalafil compared with placebo. ;Primary end point(s): Efficacy and safety of tadalafil 5 mg (or 2.5 mg) taken once a day in men with erectile dysfunction who are naive to PDE5 inhibitors. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed