This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
Placebo Oral Tablet: by mouth, Once daily, for 32 weeks
Eligibility
Sex: MALEMin age: 20 YearsMax age: 70 Years
Medical Language ↔ Plain English
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
Outcomes
Primary Outcomes
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.
Time frame: at 32 weeks
Secondary Outcomes
Safety evaulation: Occurrence of any adverse events
The AE is evaluated for grade, intensity, relationship by protocol definition
Time frame: for 32 weeks
Safety evaluation: Systolic and diastolic blood pressure
by Physical exam, mmHg
Time frame: for 32 weeks
Safety evaluation: 12-lead ECG
ECG test
Time frame: for 32 weeks
Safety evaluation: Number of Participants With Abnormal Laboratory Values
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NCT03142542 - The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy | Crick | Crick