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

Phase 2

• Conditions: Endometriosis
• Interventions: Drug: Cannabinoid treatment

• Registration Number: NCT03875261
• Lead Sponsor: David Garcia Cinca

Brief Summary

This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14
• Study Start: 2019-04-01
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Cannabinoid treatment	Participants are treated with the investigational medical product

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Central sensitivity	baseline, day 15, day 30 and day 45	Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain