NCT00666809已完成2 期
Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study
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
- Bayer
- 入组人数
- 43
- 主要终点
- Total score of the Tinnitus
研究概览
简要总结
There is incidental evidence (casuistic findings) that the treatment with vardenafil of male patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement of their tinnitus.
Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic tinnitus.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic subjective cochlear tinnitus
- •No treatment of tinnitus within 4 weeks prior to study entry
- •Duration of tinnitus > 3 months
排除标准
- •Acute tinnitus
- •Intermittent tinnitus
- •History of M. Menieré
- •History of conductive deafness
- •History of psychogenic deafness
- •History of tumors of the middle ear, inner ear or cerebella-pontine angle (malignant and non malignant)
- •Patients diagnosed of multiple sclerosis
- •History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
- •Nitrates or nitric oxide donors
- •Any other concurrent treatment of tinnitus during study
- •pregnant and breast-feeding women
- •women with child-bearing potential not using adequate birth control method (Note: as adequate method of birth control oral contraception, spiral or sexual abstinence is recommended)
- •Other exclusion criteria apply according to the Summary of Product Characteristics
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total score of the Tinnitus
时间窗: 4 times in 16 weeks
次要结局
- Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)(16 weeks)
- Quality of life (SF 36 Questionnaire)(16 weeks)
- Serum human chorionic Gonadotropin (hcG), pregnancy test(once at screening)
- Safety and tolerability(16 weeks)
研究者
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