LONG-TERM TREATMENT OF ATROPHIC VAGINITIS WITH LOW-DOSE ESTRADIOL VAGINAL TABLETS

Fifty-one post-menopausal women suffering from symptoms of oestrogen deficiency-derived atrophic vaginitis were treated intravaginally with two therapeutic regimens based on doses of 25-mu-g 17-beta-oestradiol (E2) in an open, controlled study. All the patients received treatment daily for 2 weeks by way of induction therapy. They were then randomly allocated to either once-weekly (17 patients) or twice-weekly (34 patients) vaginal administration for a further 50 weeks as maintenance treatment. Endometrial histopathology was evaluated before and after 1 year of treatment. The effects on symptoms and oestrogen/gonadotrophin levels were determined before and after 2, 12, 24, 36 and 52 weeks of therapy. Nine women continued twice-weekly treatment for a further year, meaning that they underwent treatment for a total period of 2 years. Endometrial biopsies were obtained after 2 years of treatment. All the pretreatment endometrial biopsies indicated an atrophic endometrium. One patient out of the 14 who completed 1 year of therapy in the group treated once weekly showed weak proliferation of the endometrium, while the other 13 had an atrophic endometrium. In the group treated twice weekly, 2 out of the 31 patients who completed the study showed weak proliferation of the endometrium. The other 29 had an atrophic endometrium. All 9 women who received treatment for 2 years had an atrophic endometrium at the end of the treatment period. The twice-weekly dosage regimen gave complete relief of symptoms in almost all patients, whereas the majority of the patients in the group treated once weekly still had mild symptoms. No adverse effects were reported. Both treatment regimens offered safe long-term treatment, the twice-weekly regimen being superior to once-weekly therapy as regards relief of urogenital symptoms related to post-menopausal oestrogen deficiency.