NCT05670353

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Endometriosis
• Pelvic Pain

Interventions

Type	Name	Description
DRUG	Cannabis Derivatives	CBD 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
DRUG	Placebo	Placebo 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
DRUG	Hormonal Contraceptive Agents	All participants will be given hormonal contraceptive.

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-09-12
• Completion: 2024-11-20
• First posted: 2023-01-04
• Last updated: 2025-04-02

Locations

1 site across 1 country: Brazil