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Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

Sponsor
Jason Gilleran (Other)
Overall Status
Terminated
CT.gov ID
NCT01696825
Collaborator
(none)
3
Enrollment
1
Location
4
Arms
19
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Diazepam tablet, 5 mg, vaginal
  • Drug: Diazepam Suppository, 5 mg, vaginal
  • Drug: Diazepam Cream, 5 mg, Vaginal
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum diazepam levels measured over time [Baseline then 2 hours, 4 hours and 8 hours post-medication administration]

    Secondary Outcome Measures

    1. Side effects observed with each of three types of vaginal diazepam [Baseline and 2 hours, 4 hours and 8 hours post medication administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women's Urology Center, William Beaumont Hospital Royal Oak Michigan United States 48073

    Sponsors and Collaborators

    • Jason Gilleran

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason Gilleran, Physician, William Beaumont Hospitals
    ClinicalTrials.gov Identifier:
    NCT01696825
    Other Study ID Numbers:
    • 2012-182
    First Posted:
    Oct 1, 2012
    Last Update Posted:
    Dec 16, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Diazepam

    Study Results

    No Results Posted as of Dec 16, 2014