POSTMENOPAUSAL ESTROGEN/PROGESTIN CLINICAL CENTER

绝经后雌激素/孕激素临床中心

• 批准号: 3553251
• 负责人: TRUDY L BUSH
• 金额: $ 19.15万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-30 至 1992-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3553251
• 关键词: apolipoproteins; blood lipid; blood lipoprotein; bone density; combination chemotherapy; cooperative study; coronary disorder; disease /disorder prevention /control; disease /disorder proneness /risk; drug administration routes; endometrium; estrogens; female; hormone therapy; human subject; human therapy evaluation; longitudinal human study; osteoporosis; postmenopause; progestins

This proposal is designed to assess the impact of selected estrogen, progestin and estrogen/progestin supplementation on cardiovascular disease risk factors, coagulation parameters and bone density and strength in peri- and postmenopausal women. The weight of the evidence currently suggests that unopposed estrogen supplementation lowers the risk of death from coronary heart disease (CHD), is effective at preventing bone loss and subsequent fracture, and is not associated with an increased risk of thrombogenesis, but increases the risk of endometrial cancer in women with intact uteri. Effects of estrogen/progestin or unopposed progestin supplementation on CHD risk factors and bone have not been clearly documented. Basic questions remain regarding 1) the effects of unopposed estrogen on CHD risk factors and bone in women using usual doses of estrogen replacement therapy; 2) the effects of adding a progestational agent to an estrogen replacement regimen on CHD risk factors and bone; and 3) the impact of unopposed progestin on CHD risk factors and bone. As part of a collaborative approach to the study of post- menopausal estrogen/progestin interventions, we propose to enroll, at minimum, 150 women aged 45 to 59 years in a randomized trial designed to assess the effect of selected estrogen, progestin and estrogen/progestin supplementation on lipids, lipoproteins, apoproteins, coagulation parameters, and bone densities. Based on modified factorial design, the trial will have six arms: (A) Oral estrogen and oral progestin; (B) Transdermal estrogen and oral progestin; (C) Oral progestin only; (D) Oral estrogen only; (E) Transdermal estrogen only; (F) Placebo Only hysterectomized women will be randomized to the unopposed estrogen arms (D & E). Participants will be followed for three years, and outcomes of interest will be assessed at specified times during the trial and at the final trial visit. The identification of a regimen which 1) provides favorable alterations in lipids and lipoproteins, 2) prevents bone loss, and 3) protects the endometrium of "at risk" women would be of significant benefit to the health and well being of all postmenopausal women.

本提案旨在评估选定的 补充雌激素、孕激素和补充雌激素/孕激素 心血管疾病危险因素、凝血参数和 围绝经期和绝经后妇女的骨密度和强度。 目前证据的份量表明，无人反对 补充雌激素可降低冠心病死亡风险 心脏病(CHD)，有效预防骨质流失和 继发性骨折，与增加的风险无关 血栓形成的风险，但增加子宫内膜癌的风险 子宫完整的女性。雌激素/孕激素或 非反对补充孕激素对冠心病危险因素和 骨骼还没有明确的记录。基本问题仍然存在 关于1)非竞争性雌激素对冠心病风险的影响 使用常用剂量雌激素的妇女的因子和骨骼 替代疗法；2)添加孕激素的效果 雌激素替代方案制剂对冠心病危险因素的影响 和骨骼；以及3)非抗孕激素对冠心病风险的影响 因素和骨骼。 作为协作方法的一部分，研究后 更年期雌激素/孕激素干预，我们建议 至少招收150名年龄在45岁至59岁之间的女性参加 旨在评估所选药物疗效的随机试验 补充雌激素、孕激素和补充雌激素/孕激素 脂类、脂蛋白、载脂蛋白、凝血参数和骨骼 密度。基于改进的析因设计，试验将有 六只胳膊： (A)口服雌激素和口服孕激素； (B)经皮雌激素和口服孕激素； (C)仅口服黄体酮； (D)仅口服雌激素； (E)仅经皮雌激素； (F)安慰剂 只有接受子宫切除的妇女才会被随机分配到没有反对意见的组 雌激素武器(D&E)。 参与者将接受为期三年的跟踪调查，结果 利息将在审判期间的特定时间进行评估。 在最后一次试探会上。一种方案的识别 1)在脂类和脂蛋白中提供有利的变化， 2)防止骨质流失，3)保护“处于危险”的子宫内膜 妇女将对妇女的健康和福祉大有裨益。 所有绝经后的女性。