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?
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
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
Start Date: October 2012
Completed Date: May 2014
Phase: Phase 1
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