A Randomized, Double Blind, Placebo Controlled, Multicentric Study to Assess the Efficacy and Safety of Udenafil Tablets in Patients Suffering From Erectile Dysfunction.

Abdi Ibrahim Ilac San. ve Tic A.S.0 sites118 target enrollmentOctober 2010

ConditionsErectile Dysfunction

InterventionsUdenafil Placebo

DrugsUdenafil Placebo

Overview

Phase: Phase 3
Intervention: Udenafil
Conditions: Erectile Dysfunction
Sponsor: Abdi Ibrahim Ilac San. ve Tic A.S.
Enrollment: 118
Primary Endpoint: IIEF
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

August 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Abdi Ibrahim Ilac San. ve Tic A.S.

Responsible Party

Sponsor

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.

Arms & Interventions

Udenafil

Active Ingredient

Intervention: Udenafil

Udenafil

Active Ingredient

Intervention: Placebo

Placebo

Intervention: Udenafil

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

IIEF

Time Frame: 8 week

Secondary Outcomes

Changes in the total score of IIEF at the end of the treatment compared to baseline.(8 week)
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)
Overall assessment of efficacy (GAQ) to the study medication at the end of the study.(8 week)