Esketamine for treating chronic pain from endometriosis
Official title: Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study
Run by Reinier de Graaf Groep · NCT06161805 · Data updated 2026-11-12
This study is testing whether esketamine can help women with endometriosis feel less chronic pelvic pain compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 56 (estimated) |
| Sponsor | Reinier de Graaf Groep Academic / other |
| Locations | 1 site (Delft) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | January 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | April 11, 2025 |
| Trial ID | NCT06161805 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pre-menopausal women over 18 years old diagnosed with endometriosis and experiencing chronic pelvic pain resistant to standard analgesics.
✕Probably not a fit
Patients who are post-menopausal or have not been diagnosed with endometriosis will likely not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of esketamine compared to a placebo in reducing chronic pelvic pain associated with endometriosis. The study will assess pain levels using the Numeric Rating Scale (NRS) and will also examine secondary outcomes such as quality of life, depressive symptoms, and side effects. Endometriosis is a chronic condition affecting many women, often leading to severe pain and reduced quality of life, and current treatment options are inadequate. By investigating esketamine, a drug known for its analgesic and anti-inflammatory properties, this trial seeks to provide a new therapeutic option for patients suffering from this debilitating condition.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce chronic pain and improve the quality of life for women with endometriosis.
How similar studies have gone: While esketamine has shown promise in treating chronic pain in other contexts, this specific application for endometriosis is novel and has not been previously reported.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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 by Sigtermans et al. (Trial NL466 (NTR507))\* according to their stable use in dose and frequency. \*in case of tramadol, amitriptylin, selective serotonin reuptake-inhibitors, gabapentin and pregabalin, the usage may also be continued during this study.
Where it's running
-
Nederlandse Endometriose Kliniek, Reinier de Graaf Gasthuis
Delft, Netherlands Recruiting
Study contacts
- Study coordinator: Mathijs Blikkendaal, MD, PhD
- Email: M.Blikkendaal@rdgg.nl
- Phone: 070 340 1222
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Immune profile test for women with chronic pelvic pain and endometriosis
This study tests a functional immune test to see if immune profiles differ in women with chronic pelvic pain and endometriosis who aren’t responding to first-line treatments.
-
Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
-
Tele-rehabilitation for chronic pelvic pain in endometriosis
This study is testing a tele-rehabilitation program to see if it can help women with endometriosis and chronic pelvic pain feel better through online sessions that include pain education and exercises.
-
Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
-
Imaging endometriosis with a special PET tracer in adult women
This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.
-
Fiber supplement for digestive symptoms in endometriosis
A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.