Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study
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 groupsSponsors and collaborators
Source ClinicalTrials.gov