Suspended

DREAMLANDCannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis

What is being tested

Cannabis Derivatives

+ Hormonal Contraceptive Agents

+ Placebo

Drug

Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Mental Disorders

Over 18 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3

Interventional

Study Start: January 2023

See protocol details

Summary

Principal SponsorUniversity of Sao Paulo

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2023

Actual date on which the first participant was enrolled.

The Dreamland study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), controlled by disease stage, participant and investigator blinded, single-site superiority trial of oral cannabis extract (CBD). CBD 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. Then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of CBD according to the same previous protocol. This research intends to : 1. Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women. 2. Assess whether the daily use of CBD, for nine weeks, will modify pain threshold. 3. Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms. 4. Assess the possible adverse effects of using CBD

Official TitleCannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis

NCT05670353

Principal SponsorUniversity of Sao Paulo

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesMental DisordersMarijuana AbuseEndometriosisFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic PainSubstance-Related DisordersFemale Urogenital DiseasesChemically-Induced Disorders

Criteria

6 inclusion criteria required to participate

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;

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8 exclusion criteria prevent from participating

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;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Ribeirão Preto, BrazilOpen Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo in Google Maps

SuspendedOne Study Center