Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

Jason Gilleran

Status and phase: Terminated; Phase 1

Conditions: Metabolism, Drug

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01696825

2012-182

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 4 patient groups

Diazepam Tablet, 5 mg, Vaginal

Experimental group

Treatment:

Drug: Diazepam tablet, 5 mg, vaginal

Diazepam Suppository, 5 mg, Vaginal

Experimental group

Treatment:

Drug: Diazepam Suppository, 5 mg, vaginal

Diazepam Cream, 5 mg, Vaginal

Experimental group

Treatment:

Drug: Diazepam Cream, 5 mg, Vaginal

Diazepam Tablet, 5 Mg, Oral

Active Comparator group

Treatment:

Drug: Diazepam Cream, 5 mg, Vaginal

Drug: Diazepam tablet, 5 mg, vaginal

Drug: Diazepam Suppository, 5 mg, vaginal