Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

Overview

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.

Full Title of Study: “COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2014

Interventions

  • Drug: Diazepam tablet, 5 mg, vaginal
    • Diazepam tablet, 5 mg, moistened and inserted vaginally
  • Drug: Diazepam Suppository, 5 mg, vaginal
    • Compounded diazepam 5 mg suppository administered vaginally
  • Drug: Diazepam Cream, 5 mg, Vaginal
    • Compounded diazepam cream, 5 mg, inserted vaginally

Arms, Groups and Cohorts

  • Experimental: Diazepam Tablet, 5 mg, Vaginal
  • Experimental: Diazepam Suppository, 5 mg, Vaginal
  • Experimental: Diazepam Cream, 5 mg, Vaginal
  • Active Comparator: Diazepam Tablet, 5 Mg, Oral

Clinical Trial Outcome Measures

Primary Measures

  • Serum diazepam levels measured over time
    • Time Frame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jason Gilleran
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jason Gilleran, Physician – William Beaumont Hospitals
  • Overall Official(s)
    • Jason Gilleran, MD, Principal Investigator, William Beaumont Hospitals

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.