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Cannabidiol for the Treatment of Pelvic Pain in Endometriosis (DREAMLAND)

TerminatedPhase 2, Phase 3NCT05670353
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The objective of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabis extract in women with endometriosis who have already undergone hormonal contraceptive treatment and surgery without satisfactory response.

Study details

Official title
Cannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis
Interventions
  • Drug: Cannabis Derivatives
  • Drug: Placebo
  • Drug: Hormonal Contraceptive Agents
Sponsor
University of Sao Paulo
Start date
2023-01-03
Primary completion
2024-09-12
Sex
Female
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Brazil
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Women with chronic pelvic pain secondary to endometriosis surgically treated, with refractory symptoms, and who are taking complementary hormone therapy; * Women over 18 years of age who wish to participate in the clinical trial; * Willingness to voluntarily participate in the study to accept randomization to either of the two treatment arms; * Participating exclusively in this clinical trial during the study period; * Possess a telephone (cell or landline) that may be available to receive daily calls throughout the study period; * Signature of the Free and Informed Consent Term (TCLE) approved by the Local Research Ethics Committee. Exclusion Criteria: * Chronic, severe or uncompensated medical conditions, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled high blood pressure, lung disease such as asthma or other chronic obstructive pulmonary disease; hematological diseases, liver diseases, chronic kidney disease in advanced stage (grade 3, 4 and 5), metabolic disturbances and immunosuppression; * Use of any medication with potential interaction with CBD/THC (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this medications; * Inability to use oral medication; * Pregnancy or lactation; * History of alcohol or drug addiction; * Smoking in the last three years; * Marijuana use in the past three months or a lifetime history of dependence; * Inability to cooperate with investigators due to cognitive impairment or mental status.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05670353