Efficacy, tolerability, and rare side effects of tibolone treatment in postmenopausal women

Objective: The purpose of this study was to assess the tolerability and side effects of tibolone (Livial(R), Organon), a synthetic steroid analogue for the treatment of postmenopausal symptoms, in a large population of patients. Method: 1189 postmenopausal patients were included in this study. The patients' blood pressure, body weight, general complaints, and the severity of their climacteric complaints were documented at baseline and after 4 months of tibolone treatment. Results: Tibolone significantly relieved all of the classical menopausal complaints. The proportion of patients with bleeding problems dropped significantly from 15.9% to 6.8%. Other complaints, such as headache, vertigo, nervousness, breast tenderness, and hirsutism were also significantly less frequent than before treatment. Only few women reported other rare side effects: and only 14.4% of women discontinued treatment prematurely. Conclusion: Tibolone provides an efficient and safe means of treating the postmenopausal syndrome in every-day practice. (C) 1999 International Federation of Gynecology and Obstetrics.