BridgeMD
EASYlight study
EU CTIS ID: 2023-508417-16-00
What this study is testing
The primary aim of the EASYlight study is to assess the effect of 8 hour esketamine infusion versus placebo (saline) on the numeric rating scale score (NRS score) for chronic pelvic pain in patients with chronic pain associated with endometriosis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All pre-menopausal women aged above 18 years
- Women (endometriosis is a condition exclusive to females)
- - Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification. This means that endometriosis is present in the following compartments: Rectovaginal space (minimal A1) and/or Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or Rectum (minimal C1) and/or Endometriosis of the intestines, diaphragm and/or Adenomyosis (according to the morphological uterus sonographic assessment (MUSA) or evident adenomyosis on the MRI) and/or Peritoneal / superficial endometriosis (diagnosed laparoscopically and not treated during surgery).
- -Mild to severe chronic pelvic pain (NRS scale >= 6). The 11-point NRS scale ranges from ‘0’ representing no pain to ‘10’ representing the worst pain imaginable.
- -Resistant to current recommended lines of analgesics (paracetamol, NSAIDs)
- -Usage of strong opioids must not have been prescribed or otherwise have been discontinued for more than 1 week.
You likely can't join if
- - Pain score <6 out of 10 (NRS) for chronic pelvic pain
- - Patients with glaucoma
- - Usage of strong opioid medication
- - Usage of xanthine derivatives or ergometrine
- - Unstable angina, heart failure, history of cerebral vascular accident (CVA)
- - Patients suffering from an active infection
See the full eligibility criteria
- All pre-menopausal women aged above 18 years
- Women (endometriosis is a condition exclusive to females)
- - Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification. This means that endometriosis is present in the following compartments: Rectovaginal space (minimal A1) and/or Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or Rectum (minimal C1) and/or Endometriosis of the intestines, diaphragm and/or Adenomyosis (according to the morphological uterus sonographic assessment (MUSA) or evident adenomyosis on the MRI) and/or Peritoneal / superficial endometriosis (diagnosed laparoscopically and not treated during surgery).
- -Mild to severe chronic pelvic pain (NRS scale >= 6). The 11-point NRS scale ranges from ‘0’ representing no pain to ‘10’ representing the worst pain imaginable.
- -Resistant to current recommended lines of analgesics (paracetamol, NSAIDs)
- -Usage of strong opioids must not have been prescribed or otherwise have been discontinued for more than 1 week.
- -An indication for endometriosis resection surgery or on the waiting list for surgical treatment
- -Ability to understand the patient information letter and to give oral and written informed consent
- -No alteration in the utilization of hormonal therapy ≤1 months prior to inclusion.
- - Pain score <6 out of 10 (NRS) for chronic pelvic pain
- - Patients with glaucoma
- - Usage of strong opioid medication
- - Usage of xanthine derivatives or ergometrine
- - Unstable angina, heart failure, history of cerebral vascular accident (CVA)
- - Patients suffering from an active infection
- - Patients with epilepsy
- - Patients trying to achieve pregnancy and or patients who are breastfeeding
- - Not being able to answer questionnaires (in Dutch)
- - Mentally incompetent (patients not able to make decisions that are in their best interests, this will be evaluated by their treating physician (e.g. patients with an intellectual disability or mental retardation))
- -Alcohol or drug abuse
- - Endometriosis affecting the bladder and ureter
- -Patient with a known (es)ketamine allergy
- -Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total), defined in protocol V4
- - Increased intracranial pressure
- - Poorly regulated hypertension, >180/100mmHg at rest
- - Patients with thyroid disease
- - Patients with cancer
- - History of psychiatric illness (schizophrenia, psychosis, delirium, manic depression)
- - Serious medical disease (e.g., cardiovascular, renal , pulmonary or liver disease)
- - Severe liver disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.