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首页> 美国政府科技报告 >Randomized Study of the Effects of Tibolone on Bone Density, Menopausal Symptoms, and Breast Density in High-Risk Women After Prophylactic Oophorectomy
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Randomized Study of the Effects of Tibolone on Bone Density, Menopausal Symptoms, and Breast Density in High-Risk Women After Prophylactic Oophorectomy

机译：替诺龙对预防性肛管切除术后高危女性骨密度，绝经期症状和乳房密度影响的随机研究

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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 has been: 1. Completion of the development and institutional IRB approval of the research protocol, recruitment and study management materials 2. Development and piloting of algorithms for symptom management; training of research nurses to use them for management of patients with menopause symptoms and breast cancer or breast cancer risk 3. Tibolone and placebo are obtained. The protocol is ready for initiation after DAMD Human Subjects approval 4. We have developed systems for patient accrual working with gynecologic oncologists in involved institutions In summary, we are ready to begin subject recruitment as soon as we receive DAMD approval to proceed.

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