NCT00194324已完成4 期
Vaginal Imaging Study to Evaluate the Effect of Exercise on the Distribution of Miconozole Nitrate OVULE
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To compare between exercise and no exercise:
研究概览
简要总结
This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina. The effect of moderate amounts of physical activity on the spread will be evaluated, and compared to no physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Not at risk for pregnancy
- •Willing to abstain from intercourse 24 hours prior to MRI
- •Regular menstrual cycles (every 23-38 days)
- •At least 10 weeks from most recent pregnancy outcome and had 2 spontaneous menstrual cycles since
- •Normal pap smear within previous 12 months
- •Negative test for yeast, bacterial vaginosis and trichomonas
- •Not allergic to any component of the formulation
- •No contraindications to MRI
- •Not participated in another investigational trial within 30 days
- •No history of condition, or finding on exam, that, in the opinion of the investigator, would make participation unsafe for the volunteer or complicate interpretation of the data
排除标准
- 未提供
结局指标
主要结局
To compare between exercise and no exercise:
Time needed for the capsule to dissolve;
Quantify and describe product distribution at 20 minute intervals within the first 90 minutes after insertion;
Quantify systemic levels of miconozole nitrate 90 minutes and 24 hours after insertion;
Quantify amount of miconozole nitrate in the vagina 90 minutes and 24 hours after insertion
次要结局
- Product distribution will be assessed by:
- Linear spread from the cervix covered by the product;
- Percent of maximal linear spread from the cervix;
- Surface area covered by the product;
- Percent of maximal surface contact;
- Presence bare spots in coating;
- Presence of product outside the introitus
研究者
研究点 (2)
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