Erectile Dysfunction MedDRA version: 14.0 Level: PT Classification code 10061461 Term: Erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: CIALIS 2.5 mg film-coated tablets
Product Name: Tadalafil
Product Code: LY450190
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TADALAFIL
CAS Number: 171596-29-5
Current Spon
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Male and aged at least 18 years. [2] Able to read, understand and provide signed informed consent. [3] 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. [4] Anticipate having the same adult female sexual partner during the study. (If a qualifying participant has more than one female partner during this time, 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.) [5] Agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication. (Patients who do not make at least four sexual attempts during the run-in period will not be enrolled in the study; these patients will be considered screen failures.) [6] Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the 4-week run-in period and the treatment period. (Patients who take any of these medications during the 4 week run-in period will not be enrolled in the study; these patients will be considered screen failures.) [7] Agree to participate in recording responses to questionnaires and other instruments used in this study. 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: [1] Previous or current treatment with tadalafil or any other PDE5 inhibitor. [2] Have any contraindication for the use of tadalafil or sildenafil citrate. [3] Have ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated or inadequately treated endocrine disease. The patient may be included if, in the opinion of the investigator, the ED persists after adequate treatment of the underlying endocrine disease. [4] Have a history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection. [5] Have a history of penile implant. [6] Have a clinically significant penile deformity in the opinion of the investigator. [7] Have communicable skin or sexually transmitted diseases, or have any rash or lesions on the penis or surrounding area. [8] Exhibit evidence of severe renal impairment at screening. [9] Exhibit clinical evidence of severe hepatic impairment at screening. [10] Exhibit haemoglobin A1c >11% at screening. [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. [12] Have met the criteria for unstable angina within 6 months before screening, or have a history of myocardial infarction or coronary artery bypass graft surgery within 90 days before screening, or percutaneous coronary intervention within 90 days before the screening. [13] Have any supraventricular arrhythmia with an uncontrolled ventricular response at rest, or have any history of spontaneous or induced sustained ventricular tachycardia, or use an automatic internal cardioverter-defibrillator. [14] Have a history of sudden cardiac arrest. [15] Exhibit any evidence of congestive heart failure within 6 months before screening. [16] Have had a new, significant cardiac conduction defect within 90 days before screening. [17] Exhibit systolic BP >170 or 100 or <50 mmHg at screening or 4 weeks later at the time of randomisation (if stress is suspected, retest under basal conditions), or have a history of malignant hypertension. [18] Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months before screening. [19] Have a history of loss of vision in one eye because of nonarteritic anterior ischaemic optic neuropathy. [20] Have known hereditary degenerative retinal disorders such as retinitis pigmentosa. [21] Have a history of human immunodeficiency virus infection. [22] Have any condition that, in the opinion of the investigator, would interfere with the patient’s ability to provide informed consent or comply with study instructions, would place the patient at increased risk, or might confound the interpretation of the study results. [23] Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®). [24] Have a history of drug, alcohol or substance abuse within the past 6 months, as assessed by the investigator at screening. [25] Have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. [26] 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 le
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint will be the time to discontinuation of randomised treatment (any cause). This will be calculated as the number of days from randomisation until the date the patient discontinues the randomised treatment.;Main Objective: The primary objective of this study is to assess the impact of tadalafil once a day (OaD) and tadalafil on demand (PRN) compared with sildenafil citrate PRN, in men with erectile dysfunction (ED) who are naïve to PDE5 inhibitors, on time to discontinuation of randomised treatment (any cause), as measured by the number of days from randomisation until the day the patient discontinues the randomised treatment.;Secondary Objective: • To assess the impact of tadalafil OaD compared with tadalafil PRN on time to discontinuation of randomised treatment. • To assess efficacy of the study treatments. • To assess patient satisfaction with the study treatments. • To assess psychosocial outcomes. • To assess the total number of switches over the 6-month treatment period. • To describe the patterns of ED treatment change and reasons for switch. • To assess the impact of an initial 8-week treatment with tadalafil OaD and tadalafil PRN compared with sildenafil citrate PRN on time to discontinuation from any study treatment, as measured by the number of days from the 8-week visit until the day the patient discontinues from any study treatment. • To assess the safety of tadalafil OaD, tadalafil PRN and sildenafil citrate PRN in men with ED who are naïve to PDE5 inhibitors, as assessed by AEs and vital signs measurements. | — |
Countries
France, Germany, Greece, Portugal, Spain, United Kingdom
Outcome results
None listed