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Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

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ClinicalTrials.gov Identifier: NCT01305083
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Abdi Ibrahim Ilac San. ve Tic A.S.

February 25, 2011
February 28, 2011
May 14, 2012
October 2010
August 2011   (Final data collection date for primary outcome measure)
IIEF [ Time Frame: 8 week ]
the change in score (baseline to Visit 4) for the Erectile Function domain score of the IIEF
Complete list of historical versions of study NCT01305083 on ClinicalTrials.gov Archive Site
  • Changes in the total score of IIEF at the end of the treatment compared to baseline. [ Time Frame: 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. [ Time Frame: 8 week ]
  • Overall assessment of efficacy (GAQ) to the study medication at the end of the study. [ Time Frame: 8 week ]
  • Changes in the total score of IIEF at the end of the treatment compared to baseline
  • 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.
  • Overall assessment of efficacy (GAQ) to the study medication at the end of the study.
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: Udenafil
    Placebo-control
  • Drug: Placebo
    Placebo
  • Active Comparator: Udenafil
    Active Ingredient
    Interventions:
    • Drug: Udenafil
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo
    Interventions:
    • Drug: Udenafil
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
120
August 2011
August 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT01305083
AI2010-01
No
Not Provided
Not Provided
Abdi Ibrahim Ilac San. ve Tic A.S.
Abdi Ibrahim Ilac San. ve Tic A.S.
Not Provided
Not Provided
Abdi Ibrahim Ilac San. ve Tic A.S.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP