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Benzodiazepine

Diazepam Tablet, 5 mg, Vaginal for Drug Metabolism

Phase 1
Waitlist Available
Led By Jason Gilleran, MD
Research Sponsored by Jason Gilleran
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Diazepam Tablet, 5 mg, VaginalExperimental Treatment1 Intervention
Group II: Diazepam Suppository, 5 mg, VaginalExperimental Treatment1 Intervention
Group III: Diazepam Cream, 5 mg, VaginalExperimental Treatment1 Intervention
Group IV: Diazepam Tablet, 5 Mg, OralActive Control3 Interventions

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Jason GilleranLead Sponsor
1 Previous Clinical Trials
23 Total Patients Enrolled
Jason Gilleran, MDPrincipal InvestigatorWilliam Beaumont Hospitals
1 Previous Clinical Trials
23 Total Patients Enrolled
~0 spots leftby Nov 2025
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