Tetridamine (2-methyl-3-methylamino-4,5,6,7-tetrahydroindazole) is a well known
analgesic and anti-inflammatory
drug. Here the activity and the tolerability of a new 0.134%
tetridamine formulation in rats and women, are reported. Anti-inflammatory and
analgesic tests were performed in Sprague-Dawley rats with
carrageenin oedema; topical application of 0.134%
tetridamine solution showed a marked reduction of paw swelling (-54.4%) and
pain sensibility (-81.0%). A 28 days vaginal tolerability study performed on Sprague-Dawley rats with
tetridamine lavage (0.2 ml/rat/day) showed, in comparison with control group, no changes in haematology, coagulation, clinical biochemistry and in histological examinations of uterus and vagina. Clinical studies (4 open and 1 double-blind) were performed on 93 women suffering from
vulvovaginitis and
cervicitis by treatment of 0.134%
tetridamine vaginal lavage, two times daily, for 7 days.
Tetridamine lavage reduced or eliminated all
inflammation symptoms like burning, leucorrhea, etc. and resulted very well tolerated. From these pharmacotoxicological and clinical results we can conclude that
tetridamine vaginal lavage is a new formulation with high activity and good tolerability.