Clinical trial NCT01305083: Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Abdi Ibrahim Ilac San. ve Tic A.S.
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.
* 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.

Primary outcomes:
measure: IIEF
timeFrame: 8 week
Secondary outcomes:
measure: Changes in the total score of IIEF at the end of the treatment compared to baseline.
timeFrame: 8 week
measure: 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.
timeFrame: 8 week
measure: Overall assessment of efficacy (GAQ) to the study medication at the end of the study.
timeFrame: 8 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Mersin
country: Turkey
Study officials:
References: