Discontinuation of a clinical trial of Livial® (tibolone)

A clinical trial, the so-called LIFT study, of the medicinal product Livial® (tibolone) has been discontinued prematurely due to safety reasons.

The active substance in Livial® is tibolone, which has an effect similar to that of oestrogen and progesterone. Livial® is authorised for:

1. Treatment of menopausal discomfort (symptoms of lack of oestrogen).
2. Prevention of osteoporosis in menopausal women with an increased risk of bone fractures and who are intolerant of preventive treatment with other medicinal products or which have been contraindicated.

The LIFT study investigates the effect of Livial® as a preventive therapy for osteoporosis in elderly women. 4538 women have been recruited for the study since 2001, and their average age is 68.
The study has been discontinued due to a higher occurrence of strokes in the group of women using Livial® as compared to the group of women not using Livial® (the placebo group).
The number of fractures was decreased significantly, but the positive effect on osteoporosis is not believed to compensate for the increased risk of adverse reactions. Therefore, the trial has been discontinued.

Subjects participating in the LIFT study have been informed about the discontinuation of the study.

In 2005, approximately 5700 women were treated with Livial® in Denmark. Most of them were 50 – 64 years old. The use of Livial® (and other medicinal products for treatment of menopausal discomfort) has decreased over the past years, as different studies have shown an increased risk of breast cancer, endometrial cancer and blood clots. You can find more information about this in the product information about Livial® via the link in the fact box to the right (in Danish only).

Doctors and patients are encouraged to report possible adverse reactions to the Danish Medicines Agency.
If in doubt, patients treated with Livial® should contact their doctor.

For further information, please contact Doris Irene Stenver on tel.: +45 4488 9247.

The Danish Medicines Agency, 16 February 2006