NCT00590590已完成2 期
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
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
- 105
- 试验地点
- 48
- 主要终点
- Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
研究概览
简要总结
This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have sought doctor's care for this condition.
- •Patients must be having menstrual cycles.
排除标准
- •Patients must not have any vaginal infections.
- •Patients must not be pregnant or nursing.
- •Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.
研究组 & 干预措施
3 (Placebo)
Placebo Comparator
干预措施: placebo (Drug)
1 (Lidocaine)
Experimental
干预措施: lidocaine (Drug)
2 (Lidocaine/Diphenhydramine)
Experimental
干预措施: Lidocaine/Diphenhydramine (Drug)
结局指标
主要结局
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)
时间窗: 12 weeks
The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse
次要结局
- Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)(Baseline -12 Weeks)
- Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort](12 Weeks)
- Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain](12 weeks)
- Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be](12 Weeks)
- Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe](12 Weeks)
研究者
研究点 (48)
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