NCT04349930

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

April 13, 2020

Last Update Submit

January 12, 2021

Conditions

Interstitial CystitisBladder Pain Syndrome

Keywords

Interstitial cystitisBladder pain syndromeICBPSCBDCannabidiolHemp

Outcome Measures

Primary Outcomes (1)

  • Urinary Pain Severity Scores

    Compare the efficacy of vaginal CBD suppositories versus vaginal placebo suppositories on pain severity symptoms in IC/BPS patients, as measured by composite pain severity sub-scores of the Genitourinary Pain Index (GUPI) \& Interstitial Cystitis Symptom Index (ICSI). The score ranges from 0-27 composite score with higher scores being consistent with more symptomatic disease.

    6 weeks

Secondary Outcomes (2)

  • Urinary Symptom Severity Scores

    6 weeks

  • Marijuana Urine Drug Test

    6 weeks

Study Arms (2)

Cannabidiol

EXPERIMENTAL

CBD vaginal suppository

Drug: Cannabidiol vaginal suppository

Placebo

PLACEBO COMPARATOR

Placebo vaginal suppository

Drug: Placebo vaginal suppository

Interventions

Cannabidiol vaginal suppositoryDRUG

Cannabidiol vaginal suppository

Cannabidiol
Placebo vaginal suppositoryDRUG

Placebo vaginal suppository

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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/prior to administration of Day 1 of treatment
  • Subjects taking prescription or non-prescription medication which are substrates of CYP3A4, CYP2C19, CYP2C8, CYP2C9, CYP2C19, CYP1A2 and CYP2B6 within 14 days of the study procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Gena Dunivan, M.D.

    University of New Mexico Department of Urogynecology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-masked (patient and provider)
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Double-masked, placebo-controlled randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Associate Professor

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

January 1, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)