Health Trials

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

ConditionsEndometriosisChronic Pelvic Pain Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorReinier de Graaf Groep

About this trial

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.

Eligibility criteria

Qualifiers

Women

All pre-menopausal women aged above 18 years

Rectovaginal space (minimal A1) and/or

Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Esketamine hydrochloride
  • Placebo

Treatment groups

56 Participants
are divided into 2 treatment groups

Locations

1
Nederlandse Endometriose Kliniek, Reinier de Graaf Gasthuis Delft Netherlands

Sponsors and collaborators

Reinier de Graaf Groep

Lead sponsor

Source ClinicalTrials.gov