Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

NCT ID: NCT01305083

Last Updated: 2012-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-08-31

Brief Summary

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).

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Udenafil

Active Ingredient

Group Type: ACTIVE_COMPARATOR

Udenafil

Intervention Type: DRUG

Placebo-control

Placebo

Intervention Type: DRUG

Placebo

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Udenafil

Intervention Type: DRUG

Placebo-control

Placebo

Intervention Type: DRUG

Placebo

Interventions

Udenafil

Placebo-control

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abdi Ibrahim Ilac San. ve Tic A.S.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AI2010-01

Identifier Type: -

Identifier Source: org_study_id