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New treatment option for Endometriosis
Official title Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study
ClinicalTrials.gov ID: NCT06161805
What this study is testing
What is Esketamine hydrochloride?
Esketamine hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometriosis.
Also referred to as ketanest.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain. Secondary endpoints are to assess pain scores, side-effects, quality of life, depressive symptoms and pain coping.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- Women
- All pre-menopausal women aged above 18 years
- Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification [52]. This...
- Rectovaginal space (minimal A1) and/or
- Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or
You likely can't join if
- Pain score \<6 out of 10 (NRS) for chronic pelvic pain
- Endometriosis affecting the bladder and ureter
- Increased intracranial pressure
- Poorly regulated hypertension, \>180/100mmHg at rest
- Patients with thyroid disease
- Patients with cancer
See the full eligibility criteria
- Women
- All pre-menopausal women aged above 18 years
- Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification [52]. 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) [53, 54] 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
- Endometriosis affecting the bladder and ureter
- 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
- 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
- Patient with a known (es)ketamine allergy
- Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total) Patients are allowed to continue the following pain medications: paracetamol, non-steroidal anti-inflammatory drugs as described previously...
The study team makes the final eligibility decision.
Where it's taking place
- Delft, Netherlands
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 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Delft, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.