Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

December 12, 2014 updated by: Jason Gilleran

COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Women's Urology Center, William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diazepam Tablet, 5 mg, Vaginal
Drug: Diazepam tablet, 5 mg, vaginal
Diazepam tablet, 5 mg, moistened and inserted vaginally
Other Names:
  • Valium
Experimental: Diazepam Suppository, 5 mg, Vaginal
Drug: Diazepam Suppository, 5 mg, vaginal
Compounded diazepam 5 mg suppository administered vaginally
Other Names:
  • Valium
Experimental: Diazepam Cream, 5 mg, Vaginal
Drug: Diazepam Cream, 5 mg, Vaginal
Compounded diazepam cream, 5 mg, inserted vaginally
Other Names:
  • Valium
Active Comparator: Diazepam Tablet, 5 Mg, Oral
Drug: Diazepam tablet, 5 mg, vaginal
Diazepam tablet, 5 mg, moistened and inserted vaginally
Other Names:
  • Valium
Drug: Diazepam Suppository, 5 mg, vaginal
Compounded diazepam 5 mg suppository administered vaginally
Other Names:
  • Valium
Drug: Diazepam Cream, 5 mg, Vaginal
Compounded diazepam cream, 5 mg, inserted vaginally
Other Names:
  • Valium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and 2 hours, 4 hours and 8 hours post medication administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jason Gilleran

Investigators

  • Principal Investigator: Jason Gilleran, MD, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

October 1, 2012

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 12, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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