Erectile Dysfunction Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled, Multicentric Study to Assess the Efficacy and Safety of Udenafil Tablets in Patients Suffering From Erectile Dysfunction.
Verified date | May 2012 |
Source | Abdi Ibrahim Ilac San. ve Tic A.S. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
This randomized, double blind, placebo controlled, multicentric, clinical study will assess the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile dysfunction(ED).
Status | Completed |
Enrollment | 118 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male patients of 18 to 60 years of age. - Patients in a stable, monogamous sexual relationship with a female partner for at least 6 months and willing to maintain this relationship for the duration of the study. - Patients with established diagnosis of erectile dysfunction (ED) of organic, psychogenic or mixed etiology for at least 6 months duration. - Patient willing to attempt at least one sexual intercourse in a week for the entire treatment. Exclusion Criteria: - Patients with total erectile failure or any other sexual disorder such as hypoactive sexual desire. - Patients who have previously failed to respond to PDE-5 inhibitors like Sildenafil, Vardenafil or Tadalafil. - Patients who have used other erectile dysfunction therapies within 14 days (2 weeks) prior to entering into this study (i.e. visit 1). - Patients with hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or penile trauma. - Patients with a history of major psychiatric disorder. - Patients with a history of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease within the past 6 months. - Patients with a history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or a radical prostatectomy or radical pelvic surgery. - Patients with hypotension (<90/50) or uncontrolled hypertension (>170/100), uncontrolled diabetes, hepatic impairment (SGOT or SGPT levels > 3 x Upper Normal Limit), renal impairment (serum creatinine > 2.5mg/dl), hematological disorders such as bleeding disorders. - Patients with a history of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION). - Patients with a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism. - Patients on concomitant treatment with nitrates/nitrites(NO) donor, CYP3A4 inhibitors, CYP3A4 inducers, anticoagulants, androgens, antiandrogens or trazodone. - Patients with known hypersensitivity to PDE 5 inhibitors like Sildenafil, Vardenafil or Tadalafil. - Patient with known diagnosis to AIDS or with a positive HIV result at study screening visit. - Patients with any other serious concurrent illness or malignancy. - Patients with continuing history of alcohol and / or drug abuse. - Participation in another clinical trial in the past 30days. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abdi Ibrahim Ilac San. ve Tic A.S. |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IIEF | 8 week | No | |
Secondary | Changes in the total score of IIEF at the end of the treatment compared to baseline. | 8 week | No | |
Secondary | Changes in score of Question 3 (SEP2) and Question 4 (SEP3) of IIEF questionnaire at the end of the treatment period as compared to baseline. | 8 week | No | |
Secondary | Overall assessment of efficacy (GAQ) to the study medication at the end of the study. | 8 week | No |
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