Overview
Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
Status:
Unknown status
Unknown status
Trial end date:
2019-07-15
2019-07-15
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
David Garcia CincaCollaborators:
Dr. Christian Dursteler
Fundació Clínic per la Recerca Biomedica
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.