Randomized Study of the Effects of Tibolone on Bone Density, Menopausal Symptoms, and Breast Density in High-Risk Women After Prophylactic Oophorectomy; Annual rept. 1 Sep 2003-31 Aug 2005

摘要

The synthetic steroid tibolone has been shown to improve bone mass, mitigate menopausal symptoms and reduce breast density in women with natural menopause. It has not been evaluated in an abrupt menopause model, as occurs in women at high risk of breast cancer because of inherited risk who undergo prophylactic oophorectomy to reduce breast cancer risk. We will conduct a double-blind randomized placebo-control trial to test the hypotheses that Tibolone will accomplish these goals in high-risk premenopausal women undergoing prophylactic oophorectomy, and provide an alternative for them to manage menopause symptoms without increasing breast cancer risk. Our progress to date (report 9/1/04 - 8/31/05) has been: (1) Resubmission of revised protocol to DFCI IRB in August, 2004; (2) ORP review of protocol at meeting 03/05 were communicated to PI and required extensive revision of the protocol to eliminate the additional medications added for menopause symptom management that had not been included as part of the original proposal and were felt to affect the potential integrity of the study and (3) Preparations for resubmission of the protocol to DOD and FDA.