COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Serum diazepam levels measured over time
研究概览
简要总结
The purpose of this study is to determine which of three delivery systems of vaginal diazepam have the best systemic absorption, measured by serum diazepam levels. The three delivery systems are: moistened tablet, suppository or cream. Additionally the study will compare the side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic floor dysfunction.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provide informed consent
- •Premenopausal women > age 18
- •Able to provide urine and serum samples during the time period
排除标准
- •Current use of benzodiazepines in any form. If history of benzodiazepine use, must not have taken for one week prior to study screening and enrollment
- •Pregnancy
- •Concomitant use of any narcotic drug, ethanol, or any illicit drug use during the study period that could be deemed unsafe in combination with benzodiazepine medication use as judged by the investigators.
- •Any evidence of vaginitis on wet mount slide
- •Postmenopausal
- •Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
- •Any indication/condition/medication that the investigators identify as contraindicated in conjunction with diazepam.
研究组 & 干预措施
Diazepam Tablet, 5 mg, Vaginal
干预措施: Diazepam tablet, 5 mg, vaginal (Drug)
Diazepam Suppository, 5 mg, Vaginal
干预措施: Diazepam Suppository, 5 mg, vaginal (Drug)
Diazepam Cream, 5 mg, Vaginal
干预措施: Diazepam Cream, 5 mg, Vaginal (Drug)
Diazepam Tablet, 5 Mg, Oral
干预措施: Diazepam tablet, 5 mg, vaginal (Drug)
Diazepam Tablet, 5 Mg, Oral
干预措施: Diazepam Suppository, 5 mg, vaginal (Drug)
Diazepam Tablet, 5 Mg, Oral
干预措施: Diazepam Cream, 5 mg, Vaginal (Drug)
结局指标
主要结局
Serum diazepam levels measured over time
时间窗: Baseline then 2 hours, 4 hours and 8 hours post-medication administration
次要结局
- Side effects observed with each of three types of vaginal diazepam(Baseline and 2 hours, 4 hours and 8 hours post medication administration)
研究者
Jason Gilleran
Physician
William Beaumont Hospitals