NCT01696825

Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Jason Gilleran · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metabolism, Drug

Interventions

Type	Name	Description
DRUG	Diazepam tablet, 5 mg, vaginal	Diazepam tablet, 5 mg, moistened and inserted vaginally
DRUG	Diazepam Suppository, 5 mg, vaginal	Compounded diazepam 5 mg suppository administered vaginally
DRUG	Diazepam Cream, 5 mg, Vaginal	Compounded diazepam cream, 5 mg, inserted vaginally

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-10-01
• Last updated: 2014-12-16

Locations

1 site across 1 country: United States