Pharmacovigilance

Letter to physicians concerning the early termination of the LIBERATE clinical study

03.03.2009

In cooperation with the Agency for Medicinal Products and Medical Devices, Shering Plough d.o.o. sent a letter to physicians concerning the early termination of the LIBERATE clinical study due to a significant increase in risk of the breast cancer relapse in the group of study subjects taking the active substance tibolone in comparison with the group taking the placebo.

This clinical study has not been implemented in the Republic of Croatia.

Tibolone is indicated for the treatment of oestrogen deficiency symptoms in women who have been postmenopausal for over a year after the menopause, and for the prevention of osteoporosis in postmenopausal women with an increased risk of fracture and women with a contraindication for some other medications approved for prevention of osteoporosis.

Tibolone is contraindicated in women with a current or earlier diagnosis or suspicion of breast cancer.

The multicentric, randomised, double blind clinical study LIBERATE, which aims to test the efficacy and safety of tibolone use in women with a prior breast cancer diagnosis, was terminated early due to a significant increase in risk of the breast cancer relapse in the group of subjects taking tibolone in comparison with the group taking placebo.

Text of the letter to physicians can be found below: Pismo lije─Źnicima [pdf; 267 KB]

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