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

NCT05670353 | Terminated Phase 2 DMC

• 1 other identifier: 2021/10765-0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Pelvic Pain

Keywords

Cannabis; Endometriosis; Pelvic Pain

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with pain change of 30%

  Proportion of women with at least 30% of change in pain intensity. Pain intensity measured through visual analogue scale.

  Time points for assess: Week 1, Week 3, Week 4, Week 5, Week 7, Week 8, Week 9; Data will be reported through study completion, an average of 1 year

• Proportion of patients with pain change of 50%

  Proportion of women with at least 50% of change in pain intensity. Pain intensity measured through visual analogue scale.

  Time points for assess: Week 1, Week 3, Week 4, Week 5, Week 7, Week 8, Week 9; Data will be reported through study completion, an average of 1 year

• Quantitative change in pain intensity

  Absolute variation of pain intensity measured through visual analogue scale

  Time points for assess: Week 1, Week 3, Week 4, Week 5, Week 7, Week 8, Week 9; Data will be reported through study completion, an average of 1 year

Secondary Outcomes (11)

• Pain threshold change

  Day 0, Day 63

• Central sensitization change

  Day 0, Day 63

• Brief measure for assessing generalized anxiety disorder

  Day 0, Day 63

• Measure of the degree of depression severity

  Day 0, Day 63

• Alanine aminotransferase (ALT)

  Week 0, Week 1, Week 5, Week 9.

Study Arms (2)

Cannabis Derivatives

EXPERIMENTAL

Cannabis Derivatives (98% CBD, 2% THC) will be given orally starting at 10 mg daily and up-titrated to a maximum dose of 150 mg daily. Dose up-titration will be based on clinical response or side effects, whichever comes first. After 63 days of treatment, gradual withdrawal will be performed during one week. All patients will take hormonal contraceptives, preferably progestagen-only. All participants will perform invasive and non-invasive procedures with the nursing team. The invasive will be blood collections, to evaluate laboratory parameters. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern, as will pain threshold. In addition, they will be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database, by the study coordination team.

Drug: Cannabis Derivatives; Drug: Hormonal Contraceptive Agents

Placebo

PLACEBO COMPARATOR

Placebo will be given at the same protocol described before. The bottle, label, color and density of the contents will be the same. All patients will take hormonal contraceptives, preferably progestagen-only. Then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of active treatment according to the same previous protocol. All participants will perform invasive and non-invasive procedures with the nursing team. The invasive will be blood collections, to evaluate laboratory parameters. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern, as will pain threshold. In addition, they will be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database, by the study coordination team.

Drug: Placebo; Drug: Hormonal Contraceptive Agents

Interventions

Cannabis Derivatives DRUG

CBD 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks

Cannabis Derivatives

Placebo DRUG

Placebo 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks

Placebo

Hormonal Contraceptive Agents DRUG

All participants will be given hormonal contraceptive.

Cannabis Derivatives; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Marijuana Abuse

Interventions

Contraceptive Agents, Hormonal

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Volunteers, administrative staff, laboratory technicians, doctors who will carry out the assessments, and statisticians will be blind to the treatment group and will not know about the group treatment information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 4, 2023
• Study Start: January 3, 2023
• Primary Completion: September 12, 2024
• Study Completion: November 20, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately the following publication. No end date
• Access Criteria: Researchers who provide a methodologically sound proposal. Depending on the level of the proposed use of data, approval by an independent review committee will be required for the identified purpose.

Locations

BR (1)