Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis

Study Overview
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Brief Summary
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This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.

Official Title
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Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Cannabinoid treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Participants are treated with the investigational medical product | Drug: Cannabinoid treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure threshold in hypogastrium that induces pain | Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa | day 30 after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 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). | baseline, day 15, day 30 and day 45 | 
| Quality of Life | Quality of Life measured through the EQ-5D-5L questionnaire. | baseline, day 15, day 30 and day 45 | 
| Central sensitivity | Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire. | 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). | baseline, day 15, day 30 and day 45 | 
| about sleep quality | Visual analogue scale 0-10 about sleep quality | baseline, day 15, day 30 and day 45 |