Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

NCT01696825 | Terminated Phase 1 DMC

• 1 other identifier: 2012-182
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism, Drug

Outcome Measures

Primary Outcomes (1)

• Serum diazepam levels measured over time

  Baseline then 2 hours, 4 hours and 8 hours post-medication administration

Secondary Outcomes (1)

• Side effects observed with each of three types of vaginal diazepam

  Baseline and 2 hours, 4 hours and 8 hours post medication administration

Study Arms (4)

Diazepam Tablet, 5 mg, Vaginal

EXPERIMENTAL

Drug: Diazepam tablet, 5 mg, vaginal

Diazepam Suppository, 5 mg, Vaginal

EXPERIMENTAL

Drug: Diazepam Suppository, 5 mg, vaginal

Diazepam Cream, 5 mg, Vaginal

EXPERIMENTAL

Drug: Diazepam Cream, 5 mg, Vaginal

Diazepam Tablet, 5 Mg, Oral

ACTIVE COMPARATOR

Drug: Diazepam tablet, 5 mg, vaginal; Drug: Diazepam Suppository, 5 mg, vaginal; Drug: Diazepam Cream, 5 mg, Vaginal

Interventions

Diazepam tablet, 5 mg, vaginal DRUG

Diazepam tablet, 5 mg, moistened and inserted vaginally

Also known as: Valium

Diazepam Tablet, 5 Mg, Oral; Diazepam Tablet, 5 mg, Vaginal

Diazepam Suppository, 5 mg, vaginal DRUG

Compounded diazepam 5 mg suppository administered vaginally

Also known as: Valium

Diazepam Suppository, 5 mg, Vaginal; Diazepam Tablet, 5 Mg, Oral

Diazepam Cream, 5 mg, Vaginal DRUG

Compounded diazepam cream, 5 mg, inserted vaginally

Also known as: Valium

Diazepam Cream, 5 mg, Vaginal; Diazepam Tablet, 5 Mg, Oral

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide informed consent
• Premenopausal women \> age 18
• Able to provide urine and serum samples during the time period

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jason Gilleran: lead

Study Sites (1)

Women's Urology Center, William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Interventions

Diazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jason Gilleran, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 1, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)