Study of the effect of cannabis in relieving the symptoms of endometriosis

Phase 1

• Conditions: Deep endometriosis; MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-004378-92-ES
• Lead Sponsor: Fundació Clínic per la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Patients previously submitted to open abdominal surgery.
2. History of cancer.
3. Suspicion or diagnosis of endocrine, cardio-vascular or systemic pathology relevant.
4. Pregnancy or anticipation of pregnancy up to 3 months after the end of the study.
6. Current breastfeeding.
8. Use of hormonal treatment (combined oral contraception, gestagens in the 3 months prior to the study, GNRH analogs in the 6 months prior to the start of the study).
9. Use of other analgesics different from those allowed in the study.
10. Recreational or pharmacological use of cannabinoids.
11. Hypersensitivity to cannabinoids or any of the exceptions.
12. Known or suspected personal history, or family history of schizophrenia or other psychotic illnesses, severe personality disorder or other major psychiatric disorders.
13. Patients with liver or kidney failure, severe cardiovascular disease and a history of epilepsy or recurrent seizures.
14. Patients who use concomitant potent CYP3A4 enzyme inducers, such as rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Women between the ages of 18 and 40.
2. Diagnosis of deep endometriosis after clinical suspicion and confirmation by imaging test.
3. 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 ).
4. 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 hormone-releasing systems, bilateral tubal occlusion, vasectomy of the couple, barrier methods and sexual abstinence) throughout the duration of the study and up to 3 months after the end of it.
5. Acceptance of participation in the study by signing the informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified