drugset / Trial / NCT01696825

Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

NCT01696825

Phase 1 Terminated 3 enrolled Jason Gilleran
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2012-10
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Diazepam Small molecule 5 mg Intravenous