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, 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.