NCT00707187已完成2 期
Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis
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
- 120
- 试验地点
- 1
- 主要终点
- Number of Raynaud attacks
研究概览
简要总结
Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with diagnosis of scleroderma
- •Stable sexual relationship with male partner or be sexually active
- •Raynaud phenomenon at least 6 times per week
- •Willing to attempt sexual activity 1/month during study period
排除标准
- •Severe internal organ problems related to scleroderma
- •Other gynecologic problems
- •Serious depression
- •Receiving other experimental and Raynaud treatments
研究组 & 干预措施
1
Experimental
35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
干预措施: Cialis (Drug)
2
Experimental
35 placebo pills followed with 35 study medication (20 mg)
干预措施: Cialis (Drug)
结局指标
主要结局
Number of Raynaud attacks
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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