Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

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

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).

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: Udenafil

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
  • Ankara, Turkey, 06100
  • Istanbul, Turkey
  • Izmir, Turkey
  • Mersin, Turkey, 33343

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo; Drug: Udenafil; Placebo-control
ACTIVE_COMPARATOR: Udenafil; Active Ingredient	Drug: Placebo; Placebo; Drug: Udenafil; Placebo-control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IIEF	8 week

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abdi Ibrahim Ilac San. ve Tic A.S.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (ESTIMATE): February 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 14, 2012
• Last Update Submitted That Met QC Criteria: May 11, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Udenafil
• Other Study ID Numbers: AI2010-01