Randomized clinical trial for the local therapy of carpal tunnel syndrome: cortisone vs progesterone

INTERVENTION: Trade Name: LENTOGEST*IM 1F 341MG/2ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Hydroxyprogesterone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 341‐ Trade Name: TRIAMVIRGI*INIET 3FL 40MG 1ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Triamcinolone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40‐ CONDITION: ‐ mild‐to‐moderate idiopathic carpal tunnel syndrome ; MedDRA version: 9.1 Level: LLT Classification code 10007697 Term: Carpal tunnel syndrome PRIMARY OUTCOME: Main Objective: TO DEMONSTRATE THAT LOCALLY‐INJECTED PROGESTERONE MAY BE MORE BENEFICIAL THAN CORTISONE IN CARPAL TUNNEL SYNDROME Primary end point(s): TO DEMONSTRATE THAT LOCALLY‐INJECTED PROGESTERONE MAY BE MORE BENEFICIAL THAN CORTISONE IN CARPAL TUNNEL SYNDROME Secondary Objective: TO GET INSIGHT INTO THE NEUROPROTECTIVE EFFECTS OF LOCALLY‐INJECTED PROGESTERONE AT THE LEVEL OF THE PERIPHERAL NERVOUS SYSTEM IN HUMANS INCLUSION CRITERIA: ‐ they should be able to read, understand and sign the informed consent; ‐ female gender ‐ age ranging between 20 and 60 years ‐ patients experiencing hand pain and paresthesia (especially at night) limited to the median nerve distribution ‐ patients presenting neurophysiological changes indicative of a carpal tunnel syndrome of mild or moderate degree ‐ mild‐to‐moderate idiopathic carpal tunnel syndrome 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range