A Study of Pharmacokinetics and Side Effects of Vaginally Administered Diazepam
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-003589
Sponsor Protocol Number: 17-003589
About this study
The purpose of this study is to gather information on the pharmacokinetics and side effects of vaginally administered diazepam.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Established female Mayo patients age 18-50
- Baseline documentation of: BMI/weight, age, body fat composition via calipers, other medications
Exclusion Criteria:
- Contraindication to diazepam (myasthenia gravis, respiratory insufficiency, severe hepatic insufficiency, sleep apnea, acute narrow-angle glaucoma)
- Concurrent benzodiazepine or narcotic use, or any newly prescribed sedative, SSRI/SNRI, gabapentin or amitriptyline, estrogen-containing oral contraceptives
- Alcohol consumption within 24 hours
- No grapefruit juice consumption or use of erythromycin, clarithromycin, ritonavir, itraconazole, ketoconazole, nefazodone within 1 month (CYP3A4 induction)
- Prior hysterectomy
- BMI >35
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Isabel Green, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available