Trial results for the study investigating cannabidiol (CBD) for the management of endometriosis pain were posted on ClinicalTrials.gov on 2025-04-04. The study, NCT04527003, showed that the high-dose CBD group achieved a median pain score area under the curve (AUC) of 1042, compared to 2254 for the placebo group. This Phase 3 trial was terminated early with an enrollment of 12 participants.
Background
The study NCT04527003, titled 'Cannabidiol and Management of Endometriosis Pain,' aimed to investigate the effects of cannabidiol (CBD) in patients experiencing endometriosis and pelvic pain. The investigators hypothesized that CBD could improve both pain and quality of life for these patients.
Trial design
The study NCT04527003 was a Phase 3 trial, which was ultimately terminated. It enrolled 12 participants with endometriosis and pelvic pain. The study investigated the effects of cannabidiol (CBD) extract across different dosing groups. Participants were assigned to one of three groups: a placebo group, a low-dose CBD group, or a high-dose CBD group. The trial was designed to last 12 weeks, involving several onsite visits and daily pain assessments.
Key results
The trial measured 'Pain Score Area Under the Curve (AUC)' as a key outcome, with units of score on a scale*days. The median values for each group were:
- For Group A - Placebo, the median Pain Score AUC was 2254.
- For Group B - Low Dose CBD, the median Pain Score AUC was 2211.
- For Group C - High Dose CBD, the median Pain Score AUC was 1042.
What this means
The results from this terminated Phase 3 trial suggest a potential effect of high-dose cannabidiol (CBD) on reducing pain in patients with endometriosis, as indicated by a substantially lower median Pain Score AUC compared to placebo. The low-dose CBD group showed a median Pain Score AUC similar to that of the placebo group. However, the trial's termination and very limited enrollment of only 12 participants mean these findings should be interpreted with significant caution and cannot be generalized to a broader patient population without further, larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04527003, titled 'Cannabidiol and Management of Endometriosis Pain,' were posted on 2025-04-04 on clinicaltrials.gov.