Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01696825

Enrollment

Registered

2012-10-01

Start date

2012-10-31

Completion date

2014-05-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism, Drug

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.

Interventions

DRUGDiazepam tablet, 5 mg, vaginal

Diazepam tablet, 5 mg, moistened and inserted vaginally

DRUGDiazepam Suppository, 5 mg, vaginal

Compounded diazepam 5 mg suppository administered vaginally

DRUGDiazepam Cream, 5 mg, Vaginal

Compounded diazepam cream, 5 mg, inserted vaginally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Serum diazepam levels measured over time	Baseline then 2 hours, 4 hours and 8 hours post-medication administration

Secondary

Measure	Time frame
Side effects observed with each of three types of vaginal diazepam	Baseline and 2 hours, 4 hours and 8 hours post medication administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026