TCTR20181121002尚未招募3 期
Efficacy of oral disintegrating strip sildenafil for the treatment of erectile dysfunction: A prospective, Randomized trial
Goverment pharmaceutical organization (GPO)0 个研究点目标入组 120 人开始时间: 2018年11月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- Male
入选标准
- •Inclusion criteria
- •â€¢18 years or older ED patients, defined as erection hardness score (EHS)≤ 3 or International index of erectile function 5 (IIEF-5)≤ 21
- •â€¢Had a 50% or greater failure rate in maintaining erection long enough to achieve successful intercourse
- •â€¢ED symptoms persist at least 3 months
- •â€¢Patients were required to have been in a monogamous, heterosexual relationship for 3 months or longer and to agree to make at least 2 attempts of intercourse per month. (Patients will receive medication maximum 1 tablet/week or 1 strip/week during crossover period, total 8 tablets, 8 strips/patient)
排除标准
- •Exclusion criteria
- •â€¢Patients who have contraindications of PDE5 inhibitors (nitrate use, pre-existing intermediate to high cardiac risk factors) or an allergy or hypersensitivity to a PDE5 inhibitor or a history of consistent treatment failure or dose-limiting AEs during therapy with other PDE5 inhibitors.
- •â€¢ED that resulted from spinal cord injury or radical prostatectomy, blood glucose level greater than 270 mg/dL, and untreated hypogonadism.
- •â€¢Patients who have PSA > 4 ng/dl, clinically significant cardiac, hepatic, or renal disease; orthostatic hypotension; or uncontrolled hypertension or hypotension.
研究者
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