Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
To show non-inferiority in breast cancer recurrence of tibolone 2.5 mg versus placebo in women with climacteric symptoms who have been surgically treated for primary breast cancer within the last 5 years
Secondary outcome variables include overall survival, menopausal symptoms, bone mineral density and health-related quality of life.
up to 75 Years (Child, Adult, Senior)
December 7, 2006
July 14, 2015
† Study has passed its completion date and status has not been verified in more than two years.