Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abdi Ibrahim Ilac San. ve Tic A.S.
ClinicalTrials.gov Identifier:
NCT01305083
First received: February 25, 2011
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Erectile Dysfunction
Drug: Udenafil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Abdi Ibrahim Ilac San. ve Tic A.S.:

Primary Outcome Measures:
  • IIEF [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the total score of IIEF at the end of the treatment compared to baseline. [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall assessment of efficacy (GAQ) to the study medication at the end of the study. [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Udenafil
Active Ingredient
Drug: Udenafil
Placebo-control
Drug: Placebo
Placebo
Placebo Comparator: Placebo
Placebo
Drug: Udenafil
Placebo-control
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305083

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

No publications provided

Responsible Party: Abdi Ibrahim Ilac San. ve Tic A.S.
ClinicalTrials.gov Identifier: NCT01305083     History of Changes
Other Study ID Numbers: AI2010-01
Study First Received: February 25, 2011
Last Updated: May 11, 2012
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014