None listed
Conditions
Interventions
Drug : we will recruit a patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy (BNSRP), and assign into DA-8159 group and Placebo group with a ratio of 2:1 after radom
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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 2) IIEF-EF score =18 within 6 months before bilateral nerve-sparing radical prostatectomy, and IIEF-EF =14 at 4-6 weeks (visit 1) after bilateral nerve-sparing radical prostatectomy. 3) Presence of sexual partner more thran 6 months before bilateral nerve-sparing radical prostatectomy, and had planned to keep it during the trial 4) Agreed not to use any other erectile dysfunction medication (including both generic and specialty medicines) and other erectile dysfunction therapies during the trial period. 5) Patient agrees to voluntary participation and follow the instructions carefully, after fully hearing and understanding the details of this clinical trial
Exclusion criteria
Exclusion criteria: 1) Patient who needs additional treatment in addition to bilateral nerve- sparing radical prostatectomy 2) 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 3) If there is an uncontrolled diabetes (HbA1C> 12%) at Visit 1 4) If there is proliferative diabetic retinopathy at Visit 1 5) 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 6) History of spinal cord injury, non nerve-sparing radical prostatectomy or radical pelvic surgery 7) Hypotension below 90 / 50mmHg or uncontrolled hypertension above 170 / 100mmHg 8) Penis anatomic abnormalities (severe penile fibrosis, Peyronie's disease, etc.) 9) Presence of serious disability such as malignant tumor, lung, blood, endocrine system in Screening(Visit 1). 10) Patient who have active hepatitis B or C or who are infected with HIV virus 11) Patient who have genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency, glucose-galactose uptake disorder 12) Patient who have Hyperprolactinaemia or Hypotestosteronemia - Hyperprolactinaemia : Serum prolactin value are three times higher than normal upper limit - Hypotestosteronemia : Serum totoal testosteron value = 2.5ng/ml 13) Patient who have hyperprolactinemia or hypothyroidism - Serum AST and ALT are three times higher than normal upper limit - Serum Creatinine = 2.5 mg / dl 14) Patient who have Retinitis pigmentosa 15) Patient who have blood disease (sickle cell disease, multiple myeloma, leukemia) or bleeding disorder that can cause priapism 16) A patient with a congenital QT prolongation syndrome, or taking a drug that increases QT interval. 17) If the examiner considers that he / she is not suitable for participation in clinical trials, such as mental disorder or persistent abuse of medication 18) Patient who is taking Nitrate/Nitric oxide(NO) donor(Nitroglycerin, Sodium nitroprusside, sosorbide mononitrate/dinitrate, Amyl nitrate/nitrite, etc.) 19) Patient who is taking Guanylate Cyclase stimulator (such as Riociguat) 20) Patient who is taking warfarin 21) 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.) 22) Patient who is taking androgens (Testosterone, etc.) or anti-androgens (5a-reductase inhibitors such as Finasteride, Dutasteride and anti- androgen hormones such as Flutamide and Bicalutamide) 23) Patient who is taking Trazodone 24) Patient who received other clinical trial medications (including placebo) within 4 weeks before the screening visit 25) History of hypersensitivity reactions to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug) 26) Patient who did not respond to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug) 27) Patient who has hypoactive sexual desire 28) If the examiner judges that it is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of the patients with improvement of IIEF-EF score above the value priro to BNSRP(bilateral nerve-sparing radical prostatectomy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion (%) of the patients with IIEF-EF score =18;Change in IIEF-EF score after 20/32 weeks compared to baseline;GAQ(Global Assessment Question);IIEF-5(SHIMs) score;EPIC score | — |
Countries
Korea, Republic of
Contacts
Public ContactMieun Kim
Samsung Medical Center
Outcome results
None listed