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NCT04527003

Cannabidiol and Management of Endometriosis Pain

Terminated Phase 3 Results posted Last updated 4 April 2025
What this trial tests

Phase 3 trial testing Cannabidiol (CBD) Extract in Endometriosis in 12 participants. Terminated before completion.

Timeline
4 December 2020
Primary endpoint
29 May 2024
26 June 2024

Quick facts

Lead sponsorMilton S. Hershey Medical Center
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment12
Start date4 December 2020
Primary completion29 May 2024
Estimated completion26 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Milton S. Hershey Medical Center

Who can join

Adults 18 to 45, female only, with Endometriosis or CBD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Score Area Under the Curve (AUC) Primary · 8 weeks

Pain will be self-reported daily using the Visual Analog Scale, a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremities of 0 (no pain) and 100 (worst pain). Although the daily collection is based on the 0-100 point scale, the primary study endpoint is calculated as the area under the curve per patient using the trapezoidal rule, with an AUC range per patient of 0-5600 over 8 weeks.

GroupValue95% CI
Group A - Placebo22541803 – 2662
Group B - Low Dose CBD22111455 – 2968
Group C - High Dose CBD10421042 – 1042

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A - Placebo
Serious: 0/4 (0%)
Deaths: 0/4
Group B - Low Dose CBD
Serious: 0/3 (0%)
Deaths: 0/3
Group C - High Dose CBD
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (8 terms — click to expand)

ReactionSystemGroup A - PlaceboGroup B - Low Dose CBDGroup C - High Dose CBD
NauseaGastrointestinal disorders
DiarrheaGastrointestinal disorders
Stomach painGastrointestinal disorders
HeadachesNervous system disorders
Gagging (when taking study drug)General disorders
Night sweatsReproductive system and breast disorders
Urinary tract infectionRenal and urinary disorders
ulcer on lipGeneral disorders

Data from ClinicalTrials.gov NCT04527003 adverse events section.

Sponsor's own description

The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) in patients with endometriosis. It is believed that CBD will improve both pain and quality of life. The study will last a total of 12 weeks and involve several onsite visits in addition to daily pain assessments.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cannabinoid Formulations and Delivery Systems: Current and Future Options to Treat Pain.
    Stella B, Baratta F, Della Pepa C, Arpicco S, et al · · 2021 · cited 103× · PMID 34480749 · DOI 10.1007/s40265-021-01579-x
  2. Endometriosis: Improvements and challenges in diagnosis and symptom management.
    Saunders PTK, Whitaker LHR, Horne AW. · · 2024 · cited 22× · PMID 38897171 · DOI 10.1016/j.xcrm.2024.101596
  3. Cannabidiol usage, efficacy, and side effects: analyzing the impact of health conditions, medications, and cannabis use in a cross-sectional online pilot study.
    Binkowska AA, Jakubowska N, Redeł A, Laskowska S, et al · · 2024 · cited 9× · PMID 38487574 · DOI 10.3389/fpsyt.2024.1356009
  4. Cannabidiol in Foods and Food Supplements: Evaluation of Health Risks and Health Claims.
    Engeli BE, Lachenmeier DW, Diel P, Guth S, et al · · 2025 · cited 8× · PMID 39940347 · DOI 10.3390/nu17030489
  5. Natural products modulate programmed cell death signaling mechanism for treating endometriosis: a review.
    Zhao Z, Liu F, Yu Y, Shen Y, et al · · 2026 · PMID 41693781 · DOI 10.3389/fphar.2026.1742212
  6. A Scoping Systematic Review of Cannabis Use in Endometriosis.
    McLaren K, Erridge S, Sodergren MH. · · 2026 · PMID 41367152 · DOI 10.1111/ajo.70081
  7. Cannabidiol and ∆9-Tetrahydrocannabinol in Endometriosis: A Literature Review on Therapeutic Applications and Mechanisms.
    Godoy JR, Castilhos JP, Caruso FB, Hentschke MR. · · 2026 · PMID 41248202 · DOI 10.5935/1518-0557.20250168
  8. Research progress on natural plant metabolites targeting apoptosis for endometriosis prevention and treatment: a systematic review.
    Yu Y, Zhu Y, Gao M, Wang Y, et al · · 2025 · PMID 40703363 · DOI 10.3389/fphar.2025.1624569

Verify or expand the search:

Other trials of Cannabidiol (CBD) Extract

Trials testing the same drug.

Other recruiting trials for Endometriosis

Currently open trials in the same condition.

Other Milton S. Hershey Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04527003.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing