EndometriosisPhase 2/3DREAMLANDNCT05670353
Cannabidiol for the Treatment of Pelvic Pain in Endometriosis (DREAMLAND)
A Phase 2/3 study testing Cannabis Derivatives and Hormonal Contraceptive Agents in people with Endometriosis and Pelvic Pain, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- Cannabis Derivatives and Hormonal Contraceptive Agents
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jan 2023to 20 Nov 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Cannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis
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.
Read the 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 :
- Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women.
- Assess whether the daily use of CBD, for nine weeks, will modify pain threshold.
- Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms.
- Assess the possible adverse effects of using CBD
- Conditions
- Endometriosis, Pelvic Pain
- Being tested
- Cannabis Derivatives, Placebo, Hormonal Contraceptive Agents
- Keywords
- Cannabis, Endometriosis, Pelvic Pain
- Medical subject headings
- Endometriosis, Pelvic Pain, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis DerivativesDrug
CBD 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
PlaceboDrug
Placebo 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
Hormonal Contraceptive AgentsDrug
All participants will be given hormonal contraceptive.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Hormonal Contraceptive Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
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).
Measured: Day 0, Day 63
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.
Measured: Day 0, Day 63
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.
Measured: Day 0, Day 63
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.
Measured: Day 0, Day 63
Alanine aminotransferase (ALT)
Change in ALT concentration in plasma
Measured: Week 0, Week 1, Week 5, Week 9.
Aspartate aminotransferase (AST)
Change in AST concentration in plasma
Measured: Week 0, Week 1, Week 5, Week 9.
Glucose
Change in glucose concentration (glycemia) in plasma
Measured: Week 0, Week 1, Week 5, Week 9.
Bilirubin
Change in bilirubin concentration in plasma
Measured: Week 0, Week 1, Week 5, Week 9.
Cannabidiol (CBD)
Change in CBD concentration in plasma
Measured: Week 0, Week 1, Week 5, Week 9.
Tetrahydrocannabinol (THC)
Change in THC concentration in plasma
Measured: Week 0, Week 1, Week 5, Week 9.
Side effects
Occurrence of side effects over time during the study period (day 0-63)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start3 Jan 2023
- Primary completion12 Sep 2024
- Study completion20 Nov 2024
Why it stopped: The study was prematurely terminated due to the results of the interim analysis conducted, as outlined in the initial project plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omero Benedicto Poli Neto, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670353
- Sponsor's protocol ID
- 2021/10765-0
- Acronym
- DREAMLAND
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis
- ClinicalTrials.gov ID
- NCT05670353
- Acronym / sponsor ID
- DREAMLAND / 2021/10765-0
- Conditions
- Endometriosis, Pelvic Pain
- Keywords
- Cannabis, Endometriosis, Pelvic Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to the results of the interim analysis conducted, as outlined in the initial project plan.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women.
- Assess whether the daily use of CBD, for nine weeks, will modify pain threshold.
- Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms.
- Assess the possible adverse effects of using CBD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Derivatives | Experimental | Drug: Cannabis Derivatives, Drug: Hormonal Contraceptive AgentsCannabis 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Hormonal Contraceptive AgentsPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis DerivativesCBD 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks | Drug | Cannabis Derivatives |
| PlaceboPlacebo 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks | Drug | Placebo |
| Hormonal Contraceptive AgentsAll participants will be given hormonal contraceptive. | Drug | Cannabis Derivatives, Placebo |
Primary outcome
Proportion of patients with pain change of 30%
Time frame: 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 women with at least 30% of change in pain intensity. Pain intensity measured through visual analogue scale.
Proportion of patients with pain change of 50%
Time frame: 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 women with at least 50% of change in pain intensity. Pain intensity measured through visual analogue scale.
Quantitative change in pain intensity
Time frame: 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
Absolute variation of pain intensity measured through visual analogue scale
11 secondary outcomes
Pain threshold change
Time frame: Day 0, Day 63
Central sensitization change
Time frame: Day 0, Day 63
Brief measure for assessing generalized anxiety disorder
Time frame: Day 0, Day 63
Measure of the degree of depression severity
Time frame: Day 0, Day 63
Alanine aminotransferase (ALT)
Time frame: Week 0, Week 1, Week 5, Week 9.
Aspartate aminotransferase (AST)
Time frame: Week 0, Week 1, Week 5, Week 9.
Glucose
Time frame: Week 0, Week 1, Week 5, Week 9.
Bilirubin
Time frame: Week 0, Week 1, Week 5, Week 9.
Cannabidiol (CBD)
Time frame: Week 0, Week 1, Week 5, Week 9.
Tetrahydrocannabinol (THC)
Time frame: Week 0, Week 1, Week 5, Week 9.
Side effects
Time frame: 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.
Results and safety
The study was stopped early (reason given: The study was prematurely terminated due to the results of the interim analysis conducted, as outlined in the initial project plan.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabis Derivatives and Hormonal Contraceptive Agents in people with Endometriosis and Pelvic Pain, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was prematurely terminated due to the results of the interim analysis conducted, as outlined in the initial project plan.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with pain change of 30% (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.