NCT02477436已完成2 期
A Randomized, Placebo Controlled, Double Blind, Multicenter Therapeutic Exploratory Clinical Study for the Evaluation of the Efficacy and Safety of Avanafil in the Patients With Erectile Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Change of erectile (EF) domain score in the international index of erectile function (IIEF) questionnaire
研究概览
简要总结
This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of Avanafil 50mg, 100mg, 200mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, Avanafil 50mg, 100mg or 200mg 30 minutes before sexual intercourse for 8 weeks.
详细描述
- Study design: Prospective, randomized, double blind, placebo-controlled, therapeutic exploratory clinical study Usage & period One capsule was administered 30minutes before sexual intercourse.It was administered only once a day.
[Evaluation endpoints]
- Safety: ① Laboratory tests: Hematological Test, Blood chemical Test, Urinalysis Vital signs: blood pressure, pulse rate ③ Adverse events and Adverse drug reaction ④12-lead ECG
- Efficacy
- Primary endpoint ▪ The change of erectile function (EF) domain score in the international index of erectile function (IIEF)
- Secondary endpoint ▪ The change of success rate in sexual encounter profile (SEP) questionnaire 2, questionnaire 3, questionnaire 4 and questionnaire 5 ▪ The change of score in IIEF questionnaire 3 and questionnaire 4, The change of score in other domains of IIEF, GEAQ (Global efficacy assessment question), Normal erectile function (IIEF EF domain score ≥ 26) rate Statistical methods
- Definition of Evaluation population Maximum efficacy evaluation population included the subjects who satisfied inclusion criteria, who took the investigational product at least once, who visited the hospital after taking the investigational product, and who got the result of efficacy evaluation. Safety-Evaluation Population consisted of the subjects who made a visit after taking the investigational product once or more and who got follow-up safety results
- Initial Comparability Discrete variables were comparatively analyzed by χ2-test, Fisher's exact test, and Successive variables were comparatively analyzed by ANOVA test or Kruskal-Wallis test.
- Efficacy Evaluation The change of EF domain score in the IIEF: Analysis of covariance(ANCOVA), in which baseline was corrected, was performed to check whether there was a difference between the placebo group and the Avanafil groups in change of EF domain score.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The male subjects who were aged 19 ~ 70 with history of erectile dysfunction for at least 6 months duration
- •The subjects who had had stable monogamous relationships with their female partners
- •Their partners were free from pregnancy and lactation and well prevent conception
- •The subjects who were judged to be suitable to the clinical study in consequence of screening test
- •The subjects who consented to participate in the clinical study in writing
- •The subjects who attempted sexual intercourses at least 4 times in separate days during 4 weeks' free run-in period, and whose failure rate was over 50%.
- •The subjects whose point were between 11 and 25 in EF domain of IIEF after 4 weeks' free run-in period
排除标准
- •The following cases were excluded from this clinical study.
- •The subjects who had spinal cord injury or who underwent radical prostatectomy
- •The subjects whose penises were anatomically deformed (Ex: server penile fibrosis, and Peyronie's disease)
- •The subjects who had erectile dysfunction due to neurogenic or endocrine cause (hyperprolactinemia, low serum testosterone levels, etc.)
- •Hyperprolactinemia: serum prolactin over 3 times higher than the upper limit
- •Low Testosterone: serum total testosterone less than the lower limit
- •The subjects who had uncontrolled major psychiatric disorder and did not accept therapies (includes major depressions and schizophrenia) or had significant neurological abnormalities (neurovascular disorder)
- •The subjects who underwent cancer chemotherapy within 1 year
- •The subjects who were addicted to alcohol or who had continuously misused dependent drugs
- •The subjects who had hepatic dysfunction or renal dysfunction as in the following:
- •Hepatic Dysfunction: GOT and GPT (glutamate-pyruvate transaminase) were three times higher than the upper limit
- •Renal Dysfunction: serum creatinine was over 2.0mg/dl
- •The subjects who had uncontrollable diabetes (FPG>180mg/dL)
- •The subjects who had proliferative diabetic retinopathy
- •The subjects who suffered from stroke, transient ischemic attacks, myocardial infarction, heart failure that needed to be medically treated, unstable angina or fatal arrhythmia or who underwent coronary artery bypass graft within 6 months
- •The subjects had serious hypotension (SBP/DBP(diastolic blood pressure) is less than 90/50mmHg in a sitting posture) or uncontrollable severe hypertension (SBP/DBP is over 170/100mmHg in a sitting posture)
- •The subjects who had hematological disorders that was likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia
- •The subjects who had retinitis pigmentosa
- •The subjects who suffered from serious GI bleeding disorder within 1 year
- •The subjects who took Viagra®, Cialis®, Levitra®, Mvix® and others within 2 weeks before the clinical study
- •The subjects who had taken the following drugs
- •① Nitrate/Nitric oxide(NO) donors(ex. Nitroglycerin, isosorbide mononitrate, amyl nitrate/nitrite, sodium nitroprusside)
- •② Androgens(ex testosterone), anti-androgen, trazodone
- •③ Anticoagulant (excludes antiplatelet drugs)
- •④ Erythromycin, itraconazole, ketoconazole, cimetidine, ritonavir, saquinavir, amprenavir, indinavir and nelfinavir that greatly affects CYP3A4 (cytochrome P450 isoenzyme 3A4)
- •The subjects who had history of hypersensitivity to the PDE(phosphodiesterase)-5 inhibitors or whose erectile dysfunction was not improved
- •The subjects who had hypoactive sexual desire
- •The subjects who had no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period
- •The subjects who took other study drugs within 30 days before this clinical study
- •The subjects who were judged to be unsuitable to the clinical study by other reasons
研究组 & 干预措施
Placebo group
Placebo Comparator
Placebo 100mg 2tablets
干预措施: Placebo (Drug)
Avanafil 50mg group
Experimental
Avanafil 50mg tablet + Placebo 100mg tablet
干预措施: Avanafil (Drug)
Avanafil 100mg group
Experimental
Avanafil 100mg tablet + Placebo 100mg tablet
干预措施: Avanafil (Drug)
Avanafil 200mg group
Experimental
Avanafil 100mg 2 tablets
干预措施: Avanafil (Drug)
结局指标
主要结局
Change of erectile (EF) domain score in the international index of erectile function (IIEF) questionnaire
时间窗: Week 4 and 8
次要结局
- The change of score in the international index of erectile function (IIEF) questionnaire 3 and 4(Week 4 and 8)
- The change of score in orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domains in international index of erectile function (IIEF)(Week 4 and 8)
- The change of success rate for SEP (Sexual encounter profile) questionnaire 2,3,4 and 5(Week 4 and 8)
- Improvement of erection on the GEAQ (Global Efficacy Assessment Question) questionnaire(Week 4 and 8)
- Normal erectile function (IIEF EF domain score ≥ 26) rate(Week 4 and 8)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of TPN171H in the Patients With Erectile DysfunctionErectile DysfunctionNCT04479917Vigonvita Life Sciences255
已完成
1 期
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy VolunteersHealthyNCT00941018Resolvyx Pharmaceuticals, Inc56
已完成
2 期
Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque PsoriasisPlaque PsoriasisNCT01230138Forward-Pharma GmbH252
已完成
3 期
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.Psychotic DisorderSchizoaffective DisorderNCT00412373Johnson & Johnson Pharmaceutical Research & Development, L.L.C.307
进行中（未招募）
2 期
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary CholangitisPBCPrimary Biliary CholangitisNCT05050136Mirum Pharmaceuticals, Inc.333