Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems
This study is currently recruiting participants.
Verified January 2013 by William Beaumont Hospitals
Sponsor:
Jason Gilleran
Information provided by (Responsible Party):
Jason Gilleran, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01696825
First received: September 27, 2012
Last updated: January 3, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696825
Contacts
| Contact: Michelle Romano, RN, BSN, BS | 248-898-1259 | michelle.romano@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: Michelle Romano, RN, BSN, BS 248-898-1259 michelle.romano@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: | January 3, 2013 |
| 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 May 19, 2013