Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by William Beaumont Hospitals
Sponsor:
Information provided by (Responsible Party):
Jason Gilleran, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01696825
First received: September 27, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Metabolism, Drug
Drug: Diazepam tablet, 5 mg, vaginal
Drug: Diazepam Suppository, 5 mg, vaginal
Drug: Diazepam Cream, 5 mg, Vaginal
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Serum diazepam levels measured over time [ Time Frame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diazepam Tablet, 5 mg, Vaginal Drug: Diazepam tablet, 5 mg, vaginal
Diazepam tablet, 5 mg, moistened and inserted vaginally
Other Name: Valium
Experimental: Diazepam Suppository, 5 mg, Vaginal Drug: Diazepam Suppository, 5 mg, vaginal
Compounded diazepam 5 mg suppository administered vaginally
Other Name: Valium
Experimental: Diazepam Cream, 5 mg, Vaginal Drug: Diazepam Cream, 5 mg, Vaginal
Compounded diazepam cream, 5 mg, inserted vaginally
Other Name: Valium
Active Comparator: Diazepam Tablet, 5 Mg, Oral Drug: Diazepam tablet, 5 mg, vaginal
Diazepam tablet, 5 mg, moistened and inserted vaginally
Other Name: Valium
Drug: Diazepam Suppository, 5 mg, vaginal
Compounded diazepam 5 mg suppository administered vaginally
Other Name: Valium
Drug: Diazepam Cream, 5 mg, Vaginal
Compounded diazepam cream, 5 mg, inserted vaginally
Other Name: Valium

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696825

Contacts
Contact: Emily Dove-Medows, CNM, MSN, 248-898-1259 Emily.dove-medows@beaumont.edu
Contact: Donna Carrico, WHNP 248-898-0898 dcarrico@beaumont.edu

Locations
United States, Michigan
Women's Urology Center, William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Emily Dove-Medows, RN, MSN    248-898-1259    Emily.Dove-medows@beaumont.edu   
Contact: Donna Carrico, WHNP    248-898-0898    dcarrico@beaumont.edu   
Sponsors and Collaborators
Jason Gilleran
Investigators
Principal Investigator: Jason Gilleran, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Jason Gilleran, Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01696825     History of Changes
Other Study ID Numbers: 2012-182
Study First Received: September 27, 2012
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on July 22, 2014