Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Greater Than or Equal to a 50% Reduction in Priapic Episodes
研究概览
简要总结
This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor sildenafil has an effect on the frequency of recurrent priapism and the quality of life of males with sickle cell disease (SCD).
详细描述
The proposed research is designed to investigate the utility of continuous, long-term PDE 5 inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with SCD. Although precise prevalence figures are not available, priapism in SCD is highly prevalent and thought to afflict approximately 40% of males, based on available literature. Additionally, the disorder exacts devastating consequences, including erectile tissue necrosis, erectile dysfunction, and psychological distress. Management of this disorder remains challenging because the mechanisms underlying priapism are incompletely understood.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ages 14 to 45, inclusive
- •Episodes of prolonged penile erection in the absence of sexual interest or desire, with an average frequency of at least twice weekly, when averaged over the previous four weeks
- •Able to provide informed consent or assent
排除标准
- •Use of chronic nitrates or recreational use of nitrate containing products
- •Use of a PDE5 (phosphodiesterase type 5)inhibitor within the previous two weeks
- •Alcohol use exceeding two standard drinks daily
- •Hypersensitivity to sildenafil
- •Estimated glomerular filtration rate <50ml/min
- •Known cirrhosis
- •Retinitis pigmentosa
- •Necessary use of a P450 3A4 inhibitor (a drug which can increase plasma levels of sildenafil when taken together)
研究组 & 干预措施
sildenafil
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
干预措施: sildenafil (Drug)
placebo
Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
干预措施: placebo (Other)
结局指标
主要结局
Greater Than or Equal to a 50% Reduction in Priapic Episodes
时间窗: change between 8 weeks post intervention and 16 weeks post intervention
A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes.
次要结局
未报告次要终点