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Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

NCT ID: NCT01696825

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolism, Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Diazepam Tablet, 5 mg, Vaginal

Group Type EXPERIMENTAL

Diazepam tablet, 5 mg, vaginal

Intervention Type DRUG

Diazepam tablet, 5 mg, moistened and inserted vaginally

Diazepam Suppository, 5 mg, Vaginal

Group Type EXPERIMENTAL

Diazepam Suppository, 5 mg, vaginal

Intervention Type DRUG

Compounded diazepam 5 mg suppository administered vaginally

Diazepam Cream, 5 mg, Vaginal

Group Type EXPERIMENTAL

Diazepam Cream, 5 mg, Vaginal

Intervention Type DRUG

Compounded diazepam cream, 5 mg, inserted vaginally

Diazepam Tablet, 5 Mg, Oral

Group Type ACTIVE_COMPARATOR

Diazepam tablet, 5 mg, vaginal

Intervention Type DRUG

Diazepam tablet, 5 mg, moistened and inserted vaginally

Diazepam Suppository, 5 mg, vaginal

Intervention Type DRUG

Compounded diazepam 5 mg suppository administered vaginally

Diazepam Cream, 5 mg, Vaginal

Intervention Type DRUG

Compounded diazepam cream, 5 mg, inserted vaginally

Interventions

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Diazepam tablet, 5 mg, vaginal

Diazepam tablet, 5 mg, moistened and inserted vaginally

Intervention Type DRUG

Diazepam Suppository, 5 mg, vaginal

Compounded diazepam 5 mg suppository administered vaginally

Intervention Type DRUG

Diazepam Cream, 5 mg, Vaginal

Compounded diazepam cream, 5 mg, inserted vaginally

Intervention Type DRUG

Other Intervention Names

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Valium Valium Valium

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jason Gilleran

OTHER

Sponsor Role lead

Responsible Party

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Jason Gilleran

Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jason Gilleran, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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Women's Urology Center, William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2012-182

Identifier Type: -

Identifier Source: org_study_id