NCT03875261

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

March 6, 2019

Last Update Submit

March 13, 2019

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Pressure threshold in hypogastrium that induces pain

    Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa

    day 30 after treatment initiation

Secondary Outcomes (8)

  • Pressure threshold in dermatomes that induces pain

    baseline, day 15, day 30 and day 45

  • Temperature threshold in dermatomes that induces pain

    baseline, day 15, day 30 and day 45

  • Intensity of the general pain

    baseline, day 15, day 30 and day 45

  • Anxiety and depression combined scale

    baseline, day 15, day 30 and day 45

  • Quality of Life

    baseline, day 15, day 30 and day 45

  • +3 more secondary outcomes

Study Arms (1)

Study arm

EXPERIMENTAL

Participants are treated with the investigational medical product

Drug: Cannabinoid treatment

Interventions

Cannabinoid treatmentDRUG

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.

Study arm

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).
  • Acceptance of participation in the study by signing the informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Christian Dursteler, MD

CONTACT

+34.93.227.54.00dursteler@clinic.cat

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 14, 2019

Study Start

April 1, 2019

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

ES(1)