Activity and tolerability of tetridamine vaginal lavage in rats and women.

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.