Tibolone (Livial® 2.5mg, Organon) is a synthetic steroid with estrogenic, progestogenic and androgenic properties. It was licensed in Singapore since 1991 for the treatment of complaints resulting from natural or artificial menopause.

In Feb 2006, the product owner, Organon, announced that the Long-Term Intervention on Fractures with Tibolone (LIFT) study was halted after reaching its primary efficacy endpoint, of decreasing the risk of new vertebral fractures in elderly osteoporotic women. However, an increased risk of stroke (ischaemic and haemorrhagic) was found in the treatment group when compared to the control group.

The LIFT trial, a placebo-controlled randomized trial started in 2001, was designed to investigate the effect of tibolone in the prevention of fractures among 4,538 subjects with osteoporosis, whose average age at baseline was 68 (SD 5.2) years old. Participants were assigned to take either 1.25mg tibolone daily or placebo. The number of new vertebral fractures is 44 (2.1%) with tibolone and 85 (4.1%) with placebo, hazard ratio 0.5 (p=0.0003). However a higher number of strokes was observed in the treatment group when compared to the control group in the first (2.4 years) years of treatment. Twenty-five (1.11%) cases of stroke were found with tibolone and 11 (0.49%) with placebo, hazard ratio 2.3 (p=0.02).