Metabolism, DrugPhase 1NCT01696825
Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems
A Phase 1 study testing Diazepam tablet, 5 mg, vaginal, Diazepam Suppository, 5 mg, vaginal and Diazepam Cream, 5 mg, Vaginal in people with Metabolism, Drug, run by Jason Gilleran at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Drug
- What is being tested?
- Diazepam tablet, 5 mg, vaginal, Diazepam Suppository, 5 mg, vaginal and Diazepam Cream, 5 mg, Vaginal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide informed consent
- Premenopausal women > age 18
- Able to provide urine and serum samples during the time period
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Women's Urology Center, William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS
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
- Being tested
- Diazepam tablet, 5 mg, vaginal, Diazepam Suppository, 5 mg, vaginal, Diazepam Cream, 5 mg, Vaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazepam tablet, 5 mg, vaginalDrug
Also called Valium
Diazepam tablet, 5 mg, moistened and inserted vaginally
Diazepam Suppository, 5 mg, vaginalDrug
Also called Valium
Compounded diazepam 5 mg suppository administered vaginally
Diazepam Cream, 5 mg, VaginalDrug
Also called Valium
Compounded diazepam cream, 5 mg, inserted vaginally
| Study group | Role | What they receive |
|---|---|---|
| Diazepam Tablet, 5 mg, Vaginal | Experimental | Not described Receives: Drug: Diazepam tablet, 5 mg, vaginal |
| Diazepam Suppository, 5 mg, Vaginal | Experimental | Not described Receives: Drug: Diazepam Suppository, 5 mg, vaginal |
| Diazepam Cream, 5 mg, Vaginal | Experimental | Not described Receives: Drug: Diazepam Cream, 5 mg, Vaginal |
| Diazepam Tablet, 5 Mg, Oral | Active comparator | Not described Receives: Drug: Diazepam tablet, 5 mg, vaginal; Drug: Diazepam Suppository, 5 mg, vaginal; Drug: Diazepam Cream, 5 mg, Vaginal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum diazepam levels measured over time
Measured: Baseline then 2 hours, 4 hours and 8 hours post-medication administration
Secondary outcomes (1)
Side effects observed with each of three types of vaginal diazepam
Measured: Baseline and 2 hours, 4 hours and 8 hours post medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism, DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Gilleran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jason Gilleran, Corewell Health East
- Investigators
- Jason Gilleran, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696825
- Sponsor's protocol ID
- 2012-182
- Status last verified
- Dec 2014
- First submitted
- 27 Sep 2012
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF ABSORPTION OF VAGINAL DIAZEPAM USING DIFFERENT DELIVERY SYSTEMS
- ClinicalTrials.gov ID
- NCT01696825
- Acronym / sponsor ID
- 2012-182
- Conditions
- Metabolism, Drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Jason GilleranUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diazepam Tablet, 5 mg, Vaginal | Experimental | Drug: Diazepam tablet, 5 mg, vaginal |
| Diazepam Suppository, 5 mg, Vaginal | Experimental | Drug: Diazepam Suppository, 5 mg, vaginal |
| Diazepam Cream, 5 mg, Vaginal | Experimental | Drug: Diazepam Cream, 5 mg, Vaginal |
| Diazepam Tablet, 5 Mg, Oral | Active comparator | Drug: Diazepam tablet, 5 mg, vaginal, Drug: Diazepam Suppository, 5 mg, vaginal, Drug: Diazepam Cream, 5 mg, Vaginal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provide informed consent
- Premenopausal women > age 18
- Able to provide urine and serum samples during the time period
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazepam tablet, 5 mg, vaginalAlso: ValiumDiazepam tablet, 5 mg, moistened and inserted vaginally | Drug | Diazepam Tablet, 5 Mg, Oral, Diazepam Tablet, 5 mg, Vaginal |
| Diazepam Suppository, 5 mg, vaginalAlso: ValiumCompounded diazepam 5 mg suppository administered vaginally | Drug | Diazepam Suppository, 5 mg, Vaginal, Diazepam Tablet, 5 Mg, Oral |
| Diazepam Cream, 5 mg, VaginalAlso: ValiumCompounded diazepam cream, 5 mg, inserted vaginally | Drug | Diazepam Cream, 5 mg, Vaginal, Diazepam Tablet, 5 Mg, Oral |
Primary outcome
Serum diazepam levels measured over time
Time frame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration
1 secondary outcome
Side effects observed with each of three types of vaginal diazepam
Time frame: Baseline and 2 hours, 4 hours and 8 hours post medication administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Gilleran, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diazepam tablet, 5 mg, vaginal, Diazepam Suppository, 5 mg, vaginal and Diazepam Cream, 5 mg, Vaginal in people with Metabolism, Drug, run by Jason Gilleran at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum diazepam levels measured over time (time frame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.