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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3
Diazepam tablet, 5 mg, moistened and inserted vaginally
Compounded diazepam 5 mg suppository administered vaginally
Compounded diazepam cream, 5 mg, inserted vaginally
Women's Urology Center, William Beaumont Hospital
Royal Oak, Michigan, United States
Serum diazepam levels measured over time
Time frame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration
Side effects observed with each of three types of vaginal diazepam
Time frame: Baseline and 2 hours, 4 hours and 8 hours post medication administration
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