A Phase 1 interventional study of Diazepam tablet, 5 mg, vaginal and Diazepam Suppository, 5 mg, vaginal in Metabolism, Drug, sponsored by Jason Gilleran. Terminated at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-16.
Sponsored by Jason Gilleran · Phase 1, Interventional, and Treatment
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.
Jason Gilleran is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Diazepam tablet, 5 mg, vaginal
Drug: Diazepam Suppository, 5 mg, vaginal
Drug: Diazepam Cream, 5 mg, Vaginal
Drug: Diazepam tablet, 5 mg, vaginal · Drug: Diazepam Suppository, 5 mg, vaginal · Drug: Diazepam Cream, 5 mg, Vaginal
Diazepam tablet, 5 mg, moistened and inserted vaginally
Also known as: Valium
Compounded diazepam 5 mg suppository administered vaginally
Also known as: Valium
Compounded diazepam cream, 5 mg, inserted vaginally
Also known as: Valium
Serum diazepam levels measured over time
Time frame: Baseline then 2 hours, 4 hours and 8 hours post-medication administration
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
This study is terminated, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diazepam
Jason Gilleran