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Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

RecruitingPhase 2

Who can join

Ages 21 and older · Women

Full 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

About the study

Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.

What is being tested

Sponsor: Mclean Hospital · Participants: 30 · Started: Feb 27, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06477406

Locations in the U.S.

MassachusettsMcLean Hospital, Belmont

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.