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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diazepam Tablet, 5 mg, Vaginal | Experimental |
| |
| Diazepam Suppository, 5 mg, Vaginal | Experimental |
| |
| Diazepam Cream, 5 mg, Vaginal | Experimental |
| |
| Diazepam Tablet, 5 Mg, Oral | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam tablet, 5 mg, vaginal | Drug | Diazepam tablet, 5 mg, moistened and inserted vaginally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum diazepam levels measured over time | Baseline then 2 hours, 4 hours and 8 hours post-medication administration |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects observed with each of three types of vaginal diazepam | Baseline and 2 hours, 4 hours and 8 hours post medication administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Gilleran, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Urology Center, William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Diazepam Suppository, 5 mg, vaginal | Drug | Compounded diazepam 5 mg suppository administered vaginally |
|
|
| Diazepam Cream, 5 mg, Vaginal | Drug | Compounded diazepam cream, 5 mg, inserted vaginally |
|
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |