LACK OF UTERINE EFFECTS OF 0.005% ESTRIOL VAGINAL GEL IN A RAT MODEL OF VAGINAL ATROPHY: A COMPARATIVE STUDY.
Dr. Juan Luis Delgado
Disclosure : Dr. Nieto and Dr. Moscoso del Prado are full time employees of Italfarmaco S.A.
12 slide(s) – English – 2012-03-28
Objective: Topical estrogen therapy is recommended for the treatment of vaginal atrophy. This study was designed to evaluate the uterotrophic effects of a new estrogen vaginal formulation (0.005% estriol vaginal gel) in comparison with other existing topical treatments (Ovestinon® and Colpotrophin®) and a placebo gel. Methods: Each one of the three studied formulations was administered vaginally to groups of ovariectomised rats with cytologically confirmed vaginal atrophy. The doses were adjusted by animal weight according to human dosage. After 14 days daily treatment, the animals were sacrificed and their vaginas and uteri removed. All uteri were weighted. Uteri and vaginas were fixed for histological evaluation. Results: All three active formulations proved to be equally effective in the cytological reversal of vaginal atrophy. However, they differ in their effects in the uteri. Ovestinon® and Colpotrophin® produced a significant increase in uterine weight, myometrial and endometrial thickness as well as histological modifications in the endometrium suggestive of estrogenic activity. In contrast, animals treated with 0.005% estriol vaginal gel, did not show any significant macroscopical or microcospical modifications of the uteri. Conclusions: A new topical estrogen formulation, 0.005% estriol vaginal gel, when tested in a rat model of vaginal atrophy, has proved to be equally effective as Ovestinon® and Colpotrophin® in the cytological reversal of vaginal atrophy but, at variance with them, does not produce any significant estrogenic effect on the uterus.