KETA-TEAM study of Ketamine in Endometriosis

KETA-TEAM A Phase 2 Study to Assess the Safety and Efficacy of Ketamine, Treatment for Endometriosis-related chronic pain as Analgesic in Médipôle - KETA-TEAM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002424-12-FR

Enrollment

Registered

2022-07-28

Start date

2022-11-17

Completion date

Unknown

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis with refractory chronic pelvic pain MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: KETAMINE RENAUDIN 10 mg/mL, solution injectable Product Name: KETAMINE RENAUDIN 10 mg/mL, solution injectable Product Code: 34009 578 524 7 4 Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults women who suffer from endometriosis with refractory chronic pelvic pain with clinically normal renal and hepatic functions, signing informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: high blood pressure, cardiac insufficiency, history of stroke or cerebral trauma. Pregnant and breastfeeding women. History of drug abuse or dependence.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of Ketamine treatment on endometriosis-related chronic pain;Secondary Objective: To assess the step 2 and 3 analgesics consumption during Ketamine use and over 1 month after its last administration / To assess the efficacy of Ketamine treatment on quality of life in patients with endometriosis up to 1 month after its end / To assess the safety of Ketamine treatment on endometriosis-related chronic pain;Primary end point(s): Pain level evaluated by the Pelvic Pain Sensitization Score (PPSS) 1 month after the 3-dose treatment;Timepoint(s) of evaluation of this end point: 1 month after the 3-dose treatment	—

Measure

Time frame

Main Objective: To assess the efficacy of Ketamine treatment on endometriosis-related chronic pain;Secondary Objective: To assess the step 2 and 3 analgesics consumption during Ketamine use and over 1 month after its last administration / To assess the efficacy of Ketamine treatment on quality of life in patients with endometriosis up to 1 month after its end / To assess the safety of Ketamine treatment on endometriosis-related chronic pain;Primary end point(s): Pain level evaluated by the Pelvic Pain Sensitization Score (PPSS) 1 month after the 3-dose treatment;Timepoint(s) of evaluation of this end point: 1 month after the 3-dose treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Step 2 and 3 analgesics consumption during Ketamine use and over 1 month after its last administration / Quality of life evaluated by the EHP-5, HAD scale and return to daily activities every month during 3 months / Incidence and severity of AEs and SAEs;Timepoint(s) of evaluation of this end point: 1 month after the 3-dose treatment	—

Countries

France

Contacts

Public ContactLaetitia Paradisi

Médipôle Hôpital Mutualiste

l.paradisi-prieur@resamut.fr330481655296

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026