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
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.
Clinical Details
Official title: COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS
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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Female.
Criteria:
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
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