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Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metabolism, Drug

Intervention: Diazepam tablet, 5 mg, vaginal (Drug); Diazepam Suppository, 5 mg, vaginal (Drug); Diazepam Cream, 5 mg, Vaginal (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Jason Gilleran

Official(s) and/or principal investigator(s):
Jason Gilleran, MD, Principal Investigator, Affiliation: William Beaumont Hospitals


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.

Clinical Details


Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Serum diazepam levels measured over time

Secondary outcome: Side effects observed with each of three types of vaginal diazepam


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.


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.

Locations and Contacts

Women's Urology Center, William Beaumont Hospital, Royal Oak, Michigan 48073, United States
Additional Information

Starting date: October 2012
Last updated: December 12, 2014

Page last updated: August 23, 2015

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