EndometriosisPhase 2EdomTHCNCT03875261
Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
A Phase 2 study testing Cannabinoid treatment in people with Endometriosis, run by David Garcia Cinca at 1 site in Spain.
Trial summary
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Cannabinoid treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 15 Jul 2019
- Phase
- Phase 2
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the ages of 18 and 40.
- Diagnosis of deep endometriosis after clinical suspicion and confirmation by imaging test.
- Pain with a score of 4 or more on a numerical visual scale of 11 levels (EVN 0-10) in the last 3 months (includes any type of pain associated with endometriosis: dysmenorrhea, dyspareunia, dyschezia, dysuria and / or pelvic pain).
- Women of childbearing age * should have a negative pregnancy test before inclusion in the study and should commit to using highly effective contraceptive methods (hormonal contraceptives, intrauterine device, intrauterine hormonal release systems, bilateral tubal occlusion, vasectomy the couple, barrier methods and sexual abstinence) during the entire duration of the study and up to 3 months after the end of it.
- Acceptance of participation in the study by signing the informed consent.
Who cannot join
- Patients previously submitted to open abdominal surgery.
- History of cancer.
- Suspicion or diagnosis of endocrine, cardio-vascular or systemic pathology relevant.
- Pregnancy or anticipation of pregnancy up to 3 months after the end of the study.
- Current breastfeeding.
- Use of hormonal treatment (combined oral contraception, progestin in the 3 months prior to the study, GNRH analogs in the 6 months prior to the start of the study).
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- Use of other analgesics different from those allowed in the study.
- Recreational or pharmacological use of cannabinoids.
- Hypersensitivity to cannabinoids or any of the exceptions.
- Known or suspected personal history, or family history of schizophrenia or other psychotic illnesses, severe personality disorder or other major psychiatric disorders.
- Patients with liver or kidney failure, severe cardiovascular disease and a history of epilepsy or recurrent seizures.
- Patients who use concomitant potent enzyme inducers of CYP3A4, such as rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Christian Dursteler, MD
About this study
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.
- Conditions
- Endometriosis
- Being tested
- Cannabinoid treatment
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabinoid treatmentDrug
Participants are treated with cannabinoid derivates with a dose between 1 to 12 puffs, each puffs contains 2,7 mg of delta-9-tetrahidrocannabinol and 2,5 mg of cannabidiol.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Participants are treated with the investigational medical product Receives: Drug: Cannabinoid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure threshold in hypogastrium that induces pain
Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa
Measured: day 30 after treatment initiation
Secondary outcomes (8)
Pressure threshold in dermatomes that induces pain
Umbral of pain versus mechanical stimulation in dermatomes L2 anterior, L2 posterior, and T1 of the dominant upper extremity.
Measured: baseline, day 15, day 30 and day 45
Temperature threshold in dermatomes that induces pain
Umbral sensation versus thermal stimulus (cold heat) in anterior central L2 dermatomes, posterior central L2, and T1 of the dominant upper extremity. Measured in ºC.
Measured: baseline, day 15, day 30 and day 45
Intensity of the general pain
Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10)
Measured: baseline, day 15, day 30 and day 45
Anxiety and depression combined scale
Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS).
Measured: baseline, day 15, day 30 and day 45
Quality of Life
Quality of Life measured through the EQ-5D-5L questionnaire.
Measured: baseline, day 15, day 30 and day 45
Central sensitivity
Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.
Measured: baseline, day 15, day 30 and day 45
Cognitive disorder measured by a list of words
Cognitive disorder measured by a list of words (immediate memory and retention) and digits (attentional capacity) of the Wechsler Memory Scale (WMS-III).
Measured: baseline, day 15, day 30 and day 45
about sleep quality
Visual analogue scale 0-10 about sleep quality
Measured: baseline, day 15, day 30 and day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Garcia Cinca
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Clínic per la Recerca Biomedica, Dr. Christian Dursteler
- Responsible party
- Sponsor-investigator, David Garcia Cinca, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875261
- Sponsor's protocol ID
- 2018-004378-92
- Other IDs
- 2018
- Acronym
- EdomTHC
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
- ClinicalTrials.gov ID
- NCT03875261
- Acronym / sponsor ID
- EdomTHC / 2018-004378-92
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- David Garcia CincaUniversity, hospital or other
- Collaborators
- Fundació Clínic per la Recerca Biomedica, Dr. Christian Dursteler
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 14 Mar 2019 (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.
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: Cannabinoid treatmentParticipants are treated with the investigational medical product |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the ages of 18 and 40.
- Diagnosis of deep endometriosis after clinical suspicion and confirmation by imaging test.
- Pain with a score of 4 or more on a numerical visual scale of 11 levels (EVN 0-10) in the last 3 months (includes any type of pain associated with endometriosis: dysmenorrhea, dyspareunia, dyschezia, dysuria and / or pelvic pain).
- Women of childbearing age * should have a negative pregnancy test before inclusion in the study and should commit to using highly effective contraceptive methods (hormonal contraceptives, intrauterine device, intrauterine hormonal release systems, bilateral tubal occlusion, vasectomy the couple, barrier methods and sexual abstinence) during the entire duration of the study and up to 3 months after the end of it.
- Acceptance of participation in the study by signing the informed consent.
Key exclusion criteria (12 listed)
- Patients previously submitted to open abdominal surgery.
- History of cancer.
- Suspicion or diagnosis of endocrine, cardio-vascular or systemic pathology relevant.
- Pregnancy or anticipation of pregnancy up to 3 months after the end of the study.
- Current breastfeeding.
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 |
|---|---|---|
| Cannabinoid treatmentParticipants are treated with cannabinoid derivates with a dose between 1 to 12 puffs, each puffs contains 2,7 mg of delta-9-tetrahidrocannabinol and 2,5 mg of cannabidiol. | Drug | Study arm |
Primary outcome
Pressure threshold in hypogastrium that induces pain
Time frame: day 30 after treatment initiation
Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa
8 secondary outcomes
Pressure threshold in dermatomes that induces pain
Time frame: baseline, day 15, day 30 and day 45
Temperature threshold in dermatomes that induces pain
Time frame: baseline, day 15, day 30 and day 45
Intensity of the general pain
Time frame: baseline, day 15, day 30 and day 45
Anxiety and depression combined scale
Time frame: baseline, day 15, day 30 and day 45
Quality of Life
Time frame: baseline, day 15, day 30 and day 45
Central sensitivity
Time frame: baseline, day 15, day 30 and day 45
Cognitive disorder measured by a list of words
Time frame: baseline, day 15, day 30 and day 45
about sleep quality
Time frame: baseline, day 15, day 30 and day 45
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabinoid treatment in people with Endometriosis, run by David Garcia Cinca at 1 site in Spain.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 14 Mar 2019. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Dursteler, MD (+34.93.227.54.00, dursteler@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure threshold in hypogastrium that induces pain (time frame: day 30 after treatment initiation). 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 14 Mar 2019.