Actively Recruiting

Phase 3
Age: 18Years - 50Years
FEMALE
NCT06161805

Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study

Led by Reinier de Graaf Groep · Updated on 2025-04-11

56

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women
  • All pre-menopausal women aged above 18 years
  • Diagnosed with endometriosis by ultrasound, MRI, or previous laparoscopic and/or diagnostic surgery according to the #Enzian classification
  • Endometriosis present in rectovaginal space, sacrouterine ligaments, cardinal ligaments, pelvic sidewall, rectum, intestines, diaphragm, adenomyosis, or peritoneal/superficial areas
  • Mild to severe chronic pelvic pain with a pain score of 6 or higher on the 11-point NRS scale
  • Resistant to current recommended analgesics such as paracetamol and NSAIDs
  • No use of strong opioids for more than 1 week prior to inclusion
  • Indication for endometriosis surgery or on waiting list for surgical treatment
  • Ability to understand study information and provide informed consent
  • No changes in hormonal therapy usage for at least 1 month before inclusion
Not Eligible

You will not qualify if you...

  • Chronic pelvic pain score less than 6 out of 10 on the NRS
  • Endometriosis affecting the bladder and ureter
  • Increased intracranial pressure
  • Poorly controlled hypertension above 180/100 mmHg at rest
  • Thyroid disease
  • Cancer
  • History of psychiatric illness including schizophrenia, psychosis, delirium, or manic depression
  • Serious medical diseases such as cardiovascular, renal, pulmonary, or liver disease
  • Severe liver disease
  • Glaucoma
  • Use of strong opioid medication
  • Use of xanthine derivatives or ergometrine
  • Unstable angina, heart failure, or history of stroke
  • Active infection
  • Epilepsy
  • Trying to become pregnant or breastfeeding
  • Unable to complete questionnaires in Dutch
  • Mentally incompetent to make informed decisions
  • Alcohol or drug abuse
  • Known allergy to esketamine
  • Abnormal liver enzyme levels at baseline including ASAT, ALAT, GGT, AF, or total bilirubin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nederlandse Endometriose Kliniek, Reinier de Graaf Gasthuis

Delft, Netherlands

Actively Recruiting

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Research Team

M

Mathijs Blikkendaal, MD, PhD

CONTACT

R

Rozemarijn de Koning, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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