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| Name | Class |
|---|---|
| Dong-A ST Co., Ltd. | INDUSTRY |
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This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Udenafil 75mg | Experimental | Drug: Udenafil 75mg by mouth, once daily, for 32 weeks |
|
| Placebo | Placebo Comparator | Drug: placebo by mouth, once daily, for 32 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZYDENA TAB.75mg(Udenafil 75mg) | Drug | ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SeongSoo Jeon, PhD | Contact | 82-2-3410-3555 | seongsoo.jeon@samsung.com | |
| HongMo An, Master | Contact | 82-2-3410-6853 | ahm0125.an@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| SeongSoo Jeon, PhD | Samsung Medical Center | Principal Investigator |
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placebo-controlled
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double-blind
| Placebo Oral Tablet | Drug | Placebo Oral Tablet: by mouth, Once daily, for 32 weeks |
|
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 |