Abstract
Tibolone is a safe and effective therapy in early menopausal women. Its indications for use are several. It is effective in treating vasomotor symptoms. It causes some endometrial bleeding in the first few months, but this decreases during the first year more than on estrogen. Despite the bleeding, endometrial biopsies show no evidence of endometrial stimulation and there has been no evidence of endometrial hyperplasia or cancer after 2 years. It also has the advantage over selective estrogen receptor modulators (SERMs) of increasing the vaginal maturation value. At the 1.25 mg dose, tibolone is highly effective in preventing bone loss in women in the early postmenopausal years, and early reports suggest that this dose can prevent fractures in older women. In general, tibolone is well tolerated, and there has been no increase in the risk of cardiovascular events or venous thrombosis in younger postmenopausal women. In women in their mid-60s, tibolone increases the risk of stroke in the 1.25 mg dose, and although it appears to reduce fractures, the risk/benefit ratio of the 1.25 mg dose has to be taken into consideration in older women.