Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

Study Overview
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Brief Summary
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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.

Official Title
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COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS

Conditions
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Metabolism, Drug

Intervention / Treatment
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* Drug: Diazepam tablet, 5 mg, vaginal
* Drug: Diazepam Suppository, 5 mg, vaginal
* Drug: Diazepam Cream, 5 mg, Vaginal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diazepam Tablet, 5 mg, Vaginal<br> | Drug: Diazepam tablet, 5 mg, vaginal<br>* Diazepam tablet, 5 mg, moistened and inserted vaginally<br>* Other names: Valium;|
| Experimental: Diazepam Suppository, 5 mg, Vaginal<br> | Drug: Diazepam Suppository, 5 mg, vaginal<br>* Compounded diazepam 5 mg suppository administered vaginally<br>* Other names: Valium;|
| Experimental: Diazepam Cream, 5 mg, Vaginal<br> | Drug: Diazepam Cream, 5 mg, Vaginal<br>* Compounded diazepam cream, 5 mg, inserted vaginally<br>* Other names: Valium;|
| Active Comparator: Diazepam Tablet, 5 Mg, Oral<br> | Drug: Diazepam tablet, 5 mg, vaginal<br>* Diazepam tablet, 5 mg, moistened and inserted vaginally<br>* Other names: Valium;Drug: Diazepam Suppository, 5 mg, vaginal<br>* Compounded diazepam 5 mg suppository administered vaginally<br>* Other names: Valium;Drug: Diazepam Cream, 5 mg, Vaginal<br>* Compounded diazepam cream, 5 mg, inserted vaginally<br>* Other names: Valium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum diazepam levels measured over time |  | Baseline then 2 hours, 4 hours and 8 hours post-medication administration | 

Secondary Outcome Measures

| Outcome Measure | 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 |