POSTMENOPAUSAL ESTROGEN/PROGESTIN CLINICAL CENTER

绝经后雌激素/孕激素临床中心

• 批准号: 3553254
• 负责人: TRUDY L BUSH
• 金额: $ 19.64万
• 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 1994-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3553254
• 关键词: blood pressure; clinical trials; combination chemotherapy; cooperative study; disease /disorder proneness /risk; estrogens; female; fibrinogen; heart disorder; hormone therapy; human subject; human therapy evaluation; insulin; medroxyprogesterone; osteoporosis; postmenopause; progestins; transdermal drug delivery

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.

本建议旨在评估选定的 雌激素、孕酮和雌激素/孕酮补充剂， 心血管疾病危险因素、凝血参数和 绝经期和绝经后妇女的骨密度和强度。 目前的证据表明， 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， 随后发生骨折，并且与风险增加无关 血栓形成，但增加子宫内膜癌的风险， 子宫完整的女性 雌激素/孕激素的作用或 无对抗性的维生素B1补充剂对CHD危险因素的影响， 骨头没有被明确记录。 基本问题依然存在 关于1）非对抗性雌激素对CHD风险的影响 使用常规剂量雌激素的女性中的因子和骨 替代疗法; 2）添加孕激素的影响 雌激素替代治疗对冠心病危险因素的影响 和骨骼; 3）非对抗性的白细胞介素对冠心病风险的影响 因素和骨骼。 作为一个合作的方法来研究后的一部分- 绝经期雌激素/孕激素干预，我们建议， 至少招收150名年龄在45至59岁之间的妇女， 一项随机试验，旨在评估选择的 雌激素、孕酮和雌激素/孕酮补充剂， 脂质、脂蛋白、载脂蛋白、凝血参数和骨 密度 根据改良析因设计，试验将有 六臂： (A)口服雌激素和口服孕激素; (B)经皮雌激素和口服雌激素; (C)仅经口给药; (D)仅口服雌激素; (E)仅透皮雌激素; (F)安慰剂 只有子宫切除的妇女将被随机分配到无反对的 雌激素臂（D & E）。 参与者将被跟踪三年， 将在试验期间的特定时间评估利息 以及最终试验访视时。 确定一种方案， 1)提供脂质和脂蛋白的有利改变， 2)防止骨质流失，3）保护“高危”子宫内膜 妇女的健康和福祉将大大受益， 都是绝经后的女性