Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

Phase 1

Terminated

• Conditions: Metabolism, Drug
• Interventions: Drug: Diazepam tablet, 5 mg, vaginal; Drug: Diazepam Suppository, 5 mg, vaginal; Drug: Diazepam Cream, 5 mg, Vaginal

• Registration Number: NCT01696825
• Lead Sponsor: Jason Gilleran

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-27
• Study Start: 2012-10
• Study First Posted: 2012-10-01
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• Provide informed consent
• Premenopausal women > age 18
• Able to provide urine and serum samples during the time period

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diazepam Tablet, 5 Mg, Oral	Diazepam Suppository, 5 mg, vaginal	-
Diazepam Tablet, 5 Mg, Oral	Diazepam Cream, 5 mg, Vaginal	-
Diazepam Suppository, 5 mg, Vaginal	Diazepam Suppository, 5 mg, vaginal	-
Diazepam Cream, 5 mg, Vaginal	Diazepam Cream, 5 mg, Vaginal	-
Diazepam Tablet, 5 mg, Vaginal	Diazepam tablet, 5 mg, vaginal	-
Diazepam Tablet, 5 Mg, Oral	Diazepam tablet, 5 mg, vaginal	-

Primary Outcome Measures

Name	Time	Method
Serum diazepam levels measured over time	Baseline then 2 hours, 4 hours and 8 hours post-medication administration

Secondary Outcome Measures

Name	Time	Method
Side effects observed with each of three types of vaginal diazepam	Baseline and 2 hours, 4 hours and 8 hours post medication administration

Trial Locations

Locations (1)

Women's Urology Center, William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States