KCT0003093招募中未知
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
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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