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

NCT ID: NCT03875261

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-07-15

Brief Summary

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

Conditions

Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

Participants are treated with the investigational medical product

Group Type: EXPERIMENTAL

Cannabinoid treatment

Intervention Type: DRUG

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.

Interventions

Cannabinoid 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundació Clínic per la Recerca Biomedica

UNKNOWN

Sponsor Role: collaborator

Dr. Christian Dursteler

UNKNOWN

Sponsor Role: collaborator

David Garcia Cinca

OTHER

Sponsor Role: lead

Responsible Party

David Garcia Cinca

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clínic de Barcelona

Barcelona, Catalonia, Spain

Countries

Spain

Central Contacts

Christian Dursteler, MD

Role: CONTACT

dursteler@clinic.cat

+34.93.227.54.00

Facility Contacts

Christian Dursteler, MD

Role: primary

Other Identifiers

2018-004378-92

Identifier Type: -

Identifier Source: org_study_id