Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01305083
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Abdi Ibrahim Ilac San. ve Tic A.S.

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).

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Udenafil Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Udenafil
Active Ingredient
Drug: Udenafil

Drug: Placebo

Placebo Comparator: Placebo
Drug: Udenafil

Drug: Placebo

Primary Outcome Measures :
  1. IIEF [ Time Frame: 8 week ]

Secondary Outcome Measures :
  1. Changes in the total score of IIEF at the end of the treatment compared to baseline. [ Time Frame: 8 week ]
  2. 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. [ Time Frame: 8 week ]
  3. Overall assessment of efficacy (GAQ) to the study medication at the end of the study. [ Time Frame: 8 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01305083

Ankara, Turkey, 06100
Ankara, Turkey
Istanbul, Turkey
Izmir, Turkey
Mersin, Turkey, 33343
Sponsors and Collaborators
Abdi Ibrahim Ilac San. ve Tic A.S.

Responsible Party: Abdi Ibrahim Ilac San. ve Tic A.S. Identifier: NCT01305083     History of Changes
Other Study ID Numbers: AI2010-01
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action