None listed
Conditions
Interventions
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
C
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - Diabetes; - Rheumatoid arthritis; - Mixedema; - Amyloidosis; - Pregnancy; - Contraceptive drugs; - Trauma; - Arthritis and deforming arthrosis - Secondary causes of carpal tunnel sindrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Primary end point(s): TO DEMONSTRATE THAT LOCALLY-INJECTED PROGESTERONE MAY BE MORE BENEFICIAL THAN CORTISONE IN CARPAL TUNNEL SYNDROME | — |
Countries
Italy
Outcome results
None listed