Clinical trial NCT03875261: Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
Official title: Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundació Clínic per la Recerca Biomedica
name: Dr. Christian Dursteler
First posted: 2019-03-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Pressure threshold in hypogastrium that induces pain
timeFrame: day 30 after treatment initiation
Secondary outcomes:
measure: Pressure threshold in dermatomes that induces pain
timeFrame: baseline, day 15, day 30 and day 45
measure: Temperature threshold in dermatomes that induces pain
timeFrame: baseline, day 15, day 30 and day 45
measure: Intensity of the general pain
timeFrame: baseline, day 15, day 30 and day 45
measure: Anxiety and depression combined scale
timeFrame: baseline, day 15, day 30 and day 45
measure: Quality of Life
timeFrame: baseline, day 15, day 30 and day 45
measure: Central sensitivity
timeFrame: baseline, day 15, day 30 and day 45
measure: Cognitive disorder measured by a list of words
timeFrame: baseline, day 15, day 30 and day 45
measure: about sleep quality
timeFrame: baseline, day 15, day 30 and day 45
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalonia
Study officials:
References: