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

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.

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.