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Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

NCT01696825 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-12-16

No results posted yet for this study

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

Interventions

DRUG

Diazepam tablet, 5 mg, vaginal

Diazepam tablet, 5 mg, moistened and inserted vaginally

DRUG

Diazepam Suppository, 5 mg, vaginal

Compounded diazepam 5 mg suppository administered vaginally

DRUG

Diazepam Cream, 5 mg, Vaginal

Compounded diazepam cream, 5 mg, inserted vaginally

Sponsors & Collaborators

  • Jason Gilleran

    lead OTHER

Principal Investigators

  • Jason Gilleran, MD · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696825 on ClinicalTrials.gov