Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 339
- 试验地点
- 40
- 主要终点
- Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
研究概览
简要总结
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 18 years-of-age or older.
- •Stable, heterosexual relationship for at least 6 months.
- •A history of erectile dysfunction (ED) for at least 6 months
排除标准
- •Any underlying cardiovascular condition, including unstable angina pectoris
- •History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
- •Uncontrolled atrial fibrillation / flutter at screening
- •History of congenital QT prolongation
- •History of surgical prostatectomy due to prostate cancer
- •Hereditary degenerative retinal disorders
- •History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
- •Presence of penile anatomical abnormalities
- •Spinal cord injury
- •Resting or postural hypotension or hypertension
- •Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.
- •Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
- •Subjects who have been confirmed with phenylketonuria (PKU).
- •Use of any treatment for ED within 7 days of Visit 1.
研究组 & 干预措施
Vardenafil ODT (STAXYN, BAY38-9456)
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
干预措施: Vardenafil ODT (STAXYN, BAY38-9456) (Drug)
Placebo
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
时间窗: from baseline up to 12 weeks of treatment
SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)
时间窗: from baseline up to 12 weeks
The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED'.)
Change From Baseline in Success of Erection Maintenance at 12 Weeks
时间窗: from baseline up to 12 weeks of treatment
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
次要结局
- Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks(from baseline up to 12 weeks of treatment)
- Percentage of Subjects Achieving "Back to Normal" Erectile Function(up to 12 weeks of treatment)
- Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks(from baseline up to 12 weeks of treatment)
- Number of Sexual Attempts Till First Successful Attempt(up to 12 weeks of treatment)
- Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks(from baseline up to 12 weeks of treatment)
- Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks(from baseline up to 12 weeks of treatment)
- Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF(from baseline up to 12 weeks)
- Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF(from baseline up to 12 weeks)
- Change From Baseline in Ease With Erection at 12 Weeks or LOCF(from baseline up to 12 weeks)
- Change From Baseline in Confidence for Completion at 12 Weeks or LOCF(from baseline up to 12 weeks)
- Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale(up to 12 weeks of treatment)
- Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF(from baseline up to 12 weeks)
- Satisfaction With Medication at Week 12 or LOCF(up to 12 weeks)