The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial to Evaluate the Efficacy and Safety of Udenafil Dosed Once a Day in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy

Conditions
-----------------
Prostate Cancer With Radical Prostatectomy

Intervention / Treatment
-----------------
* Drug: ZYDENA TAB.75mg(Udenafil 75mg)
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged 20 or over 20 years and not more than 70 years who underwent bilateral nerve-sparing radical prostatectomy due to prostate cancer without metastasis IIEF-EF score ≥22 at 1-8 weeks before bilateral nerve-sparing radical prostatectomy, and IIEF-EF ≤16 at screening visit Presence of sexual partner from 8 weeks before bilateral nerve-sparing radical prostatectomy, and had planned to keep it during the trial Agreed not to use any other erectile dysfunction medication (including both generic and specialty medicines) and other erectile dysfunction therapies during the trial period. Patient agrees to voluntary participation and follow the instructions carefully, after fully hearing and understanding the details of this clinical trial Exclusion Criteria: Patient who needs additional treatment in addition to bilateral nerve- sparing radical prostatectomy Use Inhibitors of PDE-5 (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and Generic Medicines) or autologous injections of vasodilators or other erectile dysfunction therapies for erectile dysfunction within the first 8 weeks of bilateral nerve-sparing radical prostatectomy If there is an uncontrolled diabetes (HbA1C> 12%) at Visit 1 If there is proliferative diabetic retinopathy at Visit 1 If there is a history of CABG surgery, stroke, unstable angina, myocardial infarction, life-threatening arrhythmia, or heart failure within 6 months before the screening visit History of spinal cord injury, non nerve-sparing radical prostatectomy or radical pelvic surgery Hypotension below 90 / 50mmHg or uncontrolled hypertension above 170 / 100mmHg Penis anatomic abnormalities (severe penile fibrosis, Peyronie's disease, etc.) Presence of serious disability such as malignant tumor, lung, blood, endocrine system in Visit 1 Patient who have active hepatitis B or C or who are infected with HIV virus Patient who have genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency, glucose-galactose uptake disorder Patient who have hyperprolactinemia or hypothyroidism Serum AST and ALT are three times higher than normal upper limit Serum Creatinine ≥ 2.5 mg / dl Patient who have retinitis pigmentosa Patient who have blood disease (sickle cell disease, multiple myeloma, leukemia) or bleeding disorder that can cause priapism Patient with congenital QT prolongation syndrome or those taking a drug that increases QT interval If the examiner considers that he / she is not suitable for participation in clinical trials, such as mental disorder or persistent abuse of medication Patient who is taking Nitrate / Nitric oxide (NO) donor (Nitroglycerin, Sodium nitroprusside, Isosorbide mononitrate / dinitrate, Amyl nitrate / nitrite, etc.) Patient who is taking Guanylate Cyclase stimulator (such as Riociguat) Patient who is taking warfarin Patient who is taking medications or foods that affect CYP3A4 metabolism Metabolic inhibitors: Antibacterials (Erythromycin, etc.), Antifungals (Itraconazole, etc.), Antivirals (Ritonavir, Saquinavir, Amprenavir, Indinavir, Nelfinavir, etc.), H2 receptor antagonist (Cimetidine, etc), or grapefruit juice Metabolic inducers: Dexamethasone, Rifampicin, Antipyretics (Phenytoin, Phenobarbital, Carbamazepine, etc.) Patient who is taking androgens (Testosterone, etc.) or anti-androgens (5α-reductase inhibitors such as Finasteride, Dutasteride and anti- androgen hormones such as Flutamide and Bicalutamide) Patient who is taking Trazodone Patient who received other clinical trial medications (including placebo) within 4 weeks before the screening visit History of hypersensitivity reactions to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug) Patient who did not respond to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug) Patient who has hypoactive sexual desire If the examiner judges that it is not suitable for participation in this trial

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Udenafil 75mg<br>Drug: Udenafil 75mg by mouth, once daily, for 32 weeks | Drug: ZYDENA TAB.75mg(Udenafil 75mg)<br>* ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks<br>|
| Placebo Comparator: Placebo<br>Drug: placebo by mouth, once daily, for 32 weeks | Drug: Placebo Oral Tablet<br>* Placebo Oral Tablet: by mouth, Once daily, for 32 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who has IIEF-EF score ≥22 | The IIEF-EF score is International Index of Erectile Function - Erectile Function. The Questionaire is composed of 6 questions. | at 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaulation: Occurrence of any adverse events | The AE is evaluated for grade, intensity, relationship by protocol definition | for 32 weeks | 
| Safety evaluation: Systolic and diastolic blood pressure | by Physical exam, mmHg | for 32 weeks | 
| Safety evaluation: 12-lead ECG | ECG test | for 32 weeks | 
| Safety evaluation: Number of Participants With Abnormal Laboratory Values | Blood and urine test | for 32 weeks | 
| Safety evaluation:pulse rate | by Physical exam, beats per minute | for 32 weeks |