Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems



Status:Recruiting
Healthy:No
Age Range:18 - 55
Updated:2/7/2015
Start Date:October 2012
Contact:Emily Dove-Medows, CNM, MSN,
Email:Emily.dove-medows@beaumont.edu
Phone:248-898-1259

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Trial Summary
Trial Overview
Inclusion Criteria

COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS

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.


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.
We found this trial at
1
site
Women's Urology Center, William Beaumont Hospital
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
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