Objective: The purpose of this study was to assess the tolerability and sid
e effects of tibolone (Livial(R), Organon), a synthetic steroid analogue fo
r the treatment of postmenopausal symptoms, in a large population of patien
ts. Method: 1189 postmenopausal patients were included in this study. The p
atients' blood pressure, body weight, general complaints, and the severity
of their climacteric complaints were documented at baseline and after 4 mon
ths of tibolone treatment. Results: Tibolone significantly relieved all of
the classical menopausal complaints. The proportion of patients with bleedi
ng problems dropped significantly from 15.9% to 6.8%. Other complaints, suc
h as headache, vertigo, nervousness, breast tenderness, and hirsutism were
also significantly less frequent than before treatment. Only few women repo
rted other rare side effects: and only 14.4% of women discontinued treatmen
t prematurely. Conclusion: Tibolone provides an efficient and safe means of
treating the postmenopausal syndrome in every-day practice. (C) 1999 Inter
national Federation of Gynecology and Obstetrics.