Endometriosis
Conditions
Brief summary
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.
Interventions
DRUGCannabinoid treatment
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.
Sponsors
Fundació Clínic per la Recerca Biomedica
Dr. Christian Dursteler
David Garcia Cinca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure threshold in hypogastrium that induces pain | day 30 after treatment initiation | Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temperature threshold in dermatomes that induces pain | baseline, day 15, day 30 and day 45 | 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. |
| Intensity of the general pain | baseline, day 15, day 30 and day 45 | Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10) |
| Anxiety and depression combined scale | baseline, day 15, day 30 and day 45 | Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS). |
| Pressure threshold in dermatomes that induces pain | baseline, day 15, day 30 and day 45 | Umbral of pain versus mechanical stimulation in dermatomes L2 anterior, L2 posterior, and T1 of the dominant upper extremity. |
| Central sensitivity | baseline, day 15, day 30 and day 45 | Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire. |
| Cognitive disorder measured by a list of words | baseline, day 15, day 30 and day 45 | Cognitive disorder measured by a list of words (immediate memory and retention) and digits (attentional capacity) of the Wechsler Memory Scale (WMS-III). |
| about sleep quality | baseline, day 15, day 30 and day 45 | Visual analogue scale 0-10 about sleep quality |
| Quality of Life | baseline, day 15, day 30 and day 45 | Quality of Life measured through the EQ-5D-5L questionnaire. |
Countries
Spain
Contacts
Primary ContactChristian Dursteler, MD
Outcome results
None listed