NCT03142542Unknown4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 99
- 主要终点
- The proportion of patients who has IIEF-EF score ≥22
研究概览
简要总结
This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Udenafil 75mg
Experimental
Drug: Udenafil 75mg by mouth, once daily, for 32 weeks
干预措施: ZYDENA TAB.75mg(Udenafil 75mg) (Drug)
Placebo
Placebo Comparator
Drug: placebo by mouth, once daily, for 32 weeks
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
The proportion of patients who has IIEF-EF score ≥22
时间窗: at 32 weeks
The IIEF-EF score is International Index of Erectile Function - Erectile Function. The Questionaire is composed of 6 questions.
次要结局
- Safety evaluation: 12-lead ECG(for 32 weeks)
- Safety evaluation: Number of Participants With Abnormal Laboratory Values(for 32 weeks)
- Safety evaluation:pulse rate(for 32 weeks)
- Safety evaulation: Occurrence of any adverse events(for 32 weeks)
- Safety evaluation: Systolic and diastolic blood pressure(for 32 weeks)
研究者
Seong Soo Jeon
Principal Investigator
Samsung Medical Center
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