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Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

NCT06477406 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis

Interventions

DRUG

Cannabidiol

Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes.

DRUG

Placebo

An active placebo containing supplemental terpenes matched to the high-CBD product.

Sponsors & Collaborators

  • Massachusetts Life Sciences Center

    collaborator UNKNOWN

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Staci Gruber, PhD · Mclean Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06477406 on ClinicalTrials.gov