Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05670353
Other study ID # 2021/10765-0
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 3, 2023
Est. completion date August 20, 2024

Study information

Verified date May 2024
Source University of Sao Paulo
Contact Omero B Poli-Neto, MD; PhD
Phone 551636022583
Email polineto@usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date August 20, 2024
Est. primary completion date July 12, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo Ribeirão Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Pain threshold change Changes in the thermal peripheral pain thresholds: the range of temperatures at which a participant begins to perceive heat as painful: comparison between the beginning (day 0) and the end of the protocol (day 63). Day 0, Day 63
Secondary Central sensitization change Changes in the score from Central Sensitization Inventory between the beginning (day 0) and the end of the protocol (day 63). Total scores ranging from 0-100. Higher scores mean a worse outcome. Score higher than 40 suggest central sensitization. Day 0, Day 63
Secondary Brief measure for assessing generalized anxiety disorder Changes in the score from Generalized Anxiety Disorder (GAD7) scale between the beginning (day 0) and the end of the protocol (day 63). Total scores ranging from 0-21. Higher scores mean a worse outcome. Scores higher than 10 suggest generalized anxiety disorder. Day 0, Day 63
Secondary Measure of the degree of depression severity Changes of scores for depressive symptoms over time during the study period (day 0-63) using Patient ´s Health Questionnaire-9 (PHQ-9). Total scores ranging from 0-27. Higher scores mean a worse outcome. Scores less than or equal to 4 suggest minimal depression. Day 0, Day 63
Secondary Alanine aminotransferase (ALT) Change in ALT concentration in plasma Week 0, Week 1, Week 5, Week 9.
Secondary Aspartate aminotransferase (AST) Change in AST concentration in plasma Week 0, Week 1, Week 5, Week 9.
Secondary Glucose Change in glucose concentration (glycemia) in plasma Week 0, Week 1, Week 5, Week 9.
Secondary Bilirubin Change in bilirubin concentration in plasma Week 0, Week 1, Week 5, Week 9.
Secondary Cannabidiol (CBD) Change in CBD concentration in plasma Week 0, Week 1, Week 5, Week 9.
Secondary Tetrahydrocannabinol (THC) Change in THC concentration in plasma Week 0, Week 1, Week 5, Week 9.
Secondary Side effects Occurrence of side effects over time during the study period (day 0-63) Week 0, Week 1 (Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7), Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9. Participants will be able to establish contact with a team doctor especially to report side effects.
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4