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Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

StatusActive, Not Recruiting
PhasePhase 2
Started2024-02-27
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later across 2 updates Jun 2026 → Dec 2026
See other at-risk trials from Mclean Hospital

Amendment history

2026-10-01
notable
Enrollment closed, study ongoing
Primary completion pushed: 2026-10 → 2026-12
Completion pushed: 2026-10 → 2026-12
2026-07-17
notable
Study Status v4
Primary completion pushed: 2026-06 → 2026-10
Completion pushed: 2026-06 → 2026-10
2026-03-24
minor
Study Status, Oversight v3
Re-verified, no change to tracked fields
2025-03-14
minor
Study Status v2
Start dateestimated 2024-12→confirmed 2024-02-27
2024-11-18
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2024-08→2024-12
Study sites0→1
2024-06-21
minor
Original filing
53 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT06477406
Lead Sponsor Mclean Hospital
Collaborators: Massachusetts Life Sciences Center
Conditions Endometriosis
Enrollment 30 participants
Start Date 2024-02-27
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-30