Treatment of the recurrent cystitis in women
Conditions
Interventions
Trade Name: Inmunoferón
Product Name: Inmunoferón
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AM3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
P
Sponsors
Industial Farmacéutica Cantabria S. A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with aged between 18-75 Actual diagnosis of recurrent cystitis confirmed with positive urinalysis Two or more previous cystitis episodies in the last 6 months or three ore more in te last year (diagnosis in urinalysis of more than 1.000 UFC/ml ) treated with antibiotics. Negative pregnancy test Adoption of contraceptives devices 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Bladder lithiasis Infectious lithiasis Low bladder obstruction Bladder ureteral flow Infection of high urinary tract (pyelonephritis) Disturbances of the bladder-urethral anatomy Disturbances of the bladder-urethral fuction Feverish urinary infection Pregnancy Breast -feading period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of AM3 (Inmunoferón) in the treatment of the recurrent cysititis in women;Secondary Objective: Reduction of the irritative mictional sintomatology Germs most frequently involved in the recurrent cystitis and their sensitivity to the antibiotic treatment Evaluate the safety and the tolerability of Inmunoferon ;Primary end point(s): Reduction of the recurrences | — |
Countries
Spain
Outcome results
None listed