Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT06477406
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 27, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: High-CBD Sublingual Product
    A custom-formulated, hemp-derived, full-spectrum high-CBD sublingual solution; 0.75mL of solution will be self-administered three times daily (TID) for the duration of the CBD phase.
  • Placebo Comparator: Placebo
    Placebo solution (0.75mL) will be self-administered TID for the duration of the placebo phase.

Primary Outcome Measure

Visual Analog Scale (VAS) [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Rosie Smith, M.S.
[email protected]
617-855-2908

Find similar trials in Belmont, MA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
McLean Hospital· Belmont, MA

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