Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
NCT06477406
· ctgov
active_not_recruiting
phase phase-2
- Enrollment
- 30
- Start
- 2024-02-27
- Completion
- 2026-12-01
- Last updated
- 2026-09-30
- Has results
- False
- Countries
- United States
Conditions
Tagged with
Interventions
-
Cannabidiol
DRUG
Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes.
-
Placebo
DRUG
An active placebo containing supplemental terpenes matched to the high-CBD product.
Eligibility criteria
Inclusion Criteria:
1. Subject has provided informed consent
2. Sex assigned female at birth
3. Subject is 21 or older
4. Subject is fluent in English
5. Subject endorses at least moderate levels of pain at the baseline visit
6. Subject endorses having endometriosis
Exclusion Criteria:
1. Non-fluent English speakers
2. Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
3. Currently uses cannabis or cannabinoid products regularly
4. Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
5. Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
6. Neuropathic pain or cancer-related pain
7. Disclosure of a genetic polymorphism affecting CYP2C9 function
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine