NCT01423370已完成2 期
Multi-center, Randomized, Double-blind, Placebo/Active-controlled, Phase II Clinical Trial to Assess the Safety and Efficacy of YHD1023 in Patients With Erectile Dysfunction
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of oral YHD1023 5g or 10g on erectile dysfunction to investigate the optimal recommended dosage. Study period is 12 weeks including 4weeks of follow-up period without treatment. Study patients will fill in the international index of erectile function questionnaire and life satisfaction questionnaires.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male volunteers of aged 20 years and older with history of organic erectile dysfunction of at least 6 months duration
- •Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study
- •The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
- •Have Erectile Function(EF) domain score 25 and under as the result of the International Index of Erectile Function(IIEF)
- •Agree to make at least 4 sexual intercourse attempts on 4 separate days with the female sexual study party during the 4-week run-in period without medication and at least 50% of attempts during this period had been unsuccessful due to insufficient erection or unable to sustain penile rigidity until ejaculation
排除标准
- •Have history of stroke, myocardial infarction, or Coronary Artery Bypass Graft surgery within the last 6 months
- •Have history of cardiac failure, unstable angina, or life-threatening arrhythmia within the last 6 months
- •Shown tachyarrhythmia, heart rate over 100 times/min(e.g. arterial fibrillation, flutter)
- •Presence of hypotension as evidenced by SBP/DBP < 90/50mmHg or uncontrollable hypertension as evidenced by SBP/DBP > 170/100mmHg
- •Presence of diagnosed diabetes(HbA1C > 12%)
- •Have history of symptomatic postural hypotension within the last 6 months
- •Have history of spinal cord injury, radical prostatectomy, or pelvic surgery
- •Presence of penile anatomical deformities (e.g. severe penile fibrosis or Peyronie's disease)
- •Presence of hypogonadism(serum total testosterone under the reference lowest limit)
- •Presence of hepatic impairment(AST or ALT > 3 times of normal upper limit) or renal impairment(serum creatinine ≥ 2.5mg/dl)
- •Have history of severe gastrointestinal hemorrhage within the last 1 year
- •Have history of hematodyscrasia predisposing to priapism(e.g. sickle cell disease, multiple myeloma, or leukemia) or bleeding disorder
- •Subject who is judged to be ineligible according to their physical checkup(medical history, physical examination, ECG, laboratory values and etc.) within 56 days prior to the first administration
- •Concomitant use of one or more of nitrates/nitric oxide(NO) donor(e.g. nitroglycerine, isosorbid, mononitrate, isosorbid dinitrate, amylnitrate/nitrite, sodium nitroprusside), Trazodone, cancer chemotherapy, anticoagulants, androgens, or anti-androgens
- •Use of any PDE-5 inhibitor(e.g. Viagra, Levitra, Cialis, Yaila, or Zydena), vasodilator self-injection, or other treatments for erectile dysfunction within the last 2 weeks prior to the study
- •Participated in any other clinical trials within 30 days prior to the first administration
- •Have history of primary hypoactive sexual desire
- •Subject who is judged to be ineligible by principal investigator or sub-investigator due to mental disorder or continuous drug abuse
研究组 & 干预措施
Group A
Experimental
干预措施: YHD1023 (Drug)
Group B
Experimental
干预措施: YHD1023 (Drug)
Group C
Experimental
干预措施: YHD1023 (Drug)
Group D
Active Comparator
干预措施: Cialis (Drug)
Group E
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8
时间窗: Baseline, Week 8
次要结局
- Percentage of Improved patients from baseline in Question 3 & Question 4 of the International Index of Erectile Function(IIEF) at week 8(Baseline, Week 8)
- Mean change from baseline in other Question of International Index of Erectile Function(IIEF) domain at week 8(Baseline, Week 8)
- Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8(Baseline, Week 8)
- Percentage of Improved patients from baseline in Global Assessment Question(GAQ) at week 8(Week 8)
- Mean change in Life Satisfaction score(Week 8)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)Irritable Bowel SyndromeNCT00189813Astellas Pharma Inc691
已完成
不适用
To assess the efficacy of a block to reduce postoperative pain in breast cancer patientsCTRI/2019/08/020897Govt T D Medical College
已完成
不适用
Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility StudyErectile DysfunctionNCT04484090OHH-MED Medical Ltd28
已完成
3 期
Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile DysfunctionErectile DysfunctionNCT01901640Dong-A Pharmaceutical Co., Ltd.302
已完成
3 期
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal MenMale HypogonadismNCT01403116Clarus Therapeutics, Inc.325