The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and… (NCT04349930) | Clinical Trial Compass
WithdrawnPhase 1
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
Stopped: Need to obtain IND approval.
United States0Started 2021-01
Plain-language summary
This study seeks to exploit bladder cannabidiol receptors as a therapeutic drug target by conducting a double-masked, placebo-controlled randomized trial evaluating the effects of vaginal hemp cannabidiol (CBD) suppositories on lower urinary tract symptoms (LUTS), pain severity, and sexual function.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female Subjects ≥ 18 years of age
* Interstitial cystitis (IC) diagnosis
* English speaking/reading
* Prior treatment with one known treatment for IC: behavioral modifications, pelvic floor physical therapy, medications (amitriptyline, cimetidine, pentosane polysulfate sodium, or hydroxyzine), bladder instillations, bladder hydrodistention, cystoscopic fulguration or injection of Hunner's lesions, intradetrusor injection of botulinum toxin, or sacral neuromodulation
* Females of childbearing potential must use contraception throughout the study period (hormonal contraception, diaphragm, cervical cap, vaginal sponge, condoms, vasectomy, long acting reversible contraception)
* Females of non-child bearing potential must be post-menopausal defined as: \> 51yo with no menses within the past 12mo or history of hysterectomy or history of bilateral oophorectomy or bilateral tubal ligation
Exclusion Criteria:
* THC or cannabidiol use within 1 month prior to enrollment per patient report
* Positive urine marijuana drug test on day of study enrollment
* Plan to use concomitant THC or cannabidiol of any form during the 6 week study period
* Inability to speak/understand English
* Pregnant or planning on becoming pregnant
* Unable to be contacted for follow up by telephone
* Cocoa butter allergy
* AST or ALT greater than 3 times the upper limit of normal at time of enrollment
* Females of childbearing potential with a positive urine pregnancy test at screening/pr…