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Metabolism, Drug | Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

Metabolism, Drug research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Metabolism, Drug

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Diazepam tablet, 5 mg, vaginalDiazepam tablet, 5 mg, moistened and inserted vaginally

Drug:Diazepam Suppository, 5 mg, vaginalCompounded diazepam 5 mg suppository administered vaginally

Drug:Diazepam Cream, 5 mg, VaginalCompounded diazepam cream, 5 mg, inserted vaginally

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Diazepam Tablet, 5 mg, Vaginal

Diazepam Suppository, 5 mg, Vaginal

Diazepam Cream, 5 mg, Vaginal

Diazepam Tablet, 5 Mg, Oral

Study Status

Terminated

Start Date: October 2012

Completed Date: May 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Serum diazepam levels measured over time

Secondary Outcome: Side effects observed with each of three types of vaginal diazepam

Study sponsors, principal investigator, and references

Principal Investigator: Jason Gilleran, MD

Lead Sponsor: Jason Gilleran

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01696825

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