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

• Status: Enrolling by invitation
• Trial end date: 2023-08-20
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Contraceptive Agents; Contraceptive Agents, Hormonal

Criteria

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.