POSTMENOPAUSAL ESTROGEN & PROGESTIN INTERVENTION (PEPI) TRIAL

绝经后雌激素

• 批准号: 6265728
• 负责人: TRUDY L BUSH
• 金额: $ 6.52万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265728
• 关键词: alcoholic beverage consumption; blood pressure; body composition; bone density; clinical research; clinical trial phase I; emotions; estrogens; female; functional ability; hormone therapy; human subject; human therapy evaluation; longitudinal human study; postmenopause; progestins; quality of life; sex behavior; tobacco abuse

Rationale: The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial included 875 participants followed at seven centers for three years (123 were randomized and followed at the Hopkins center). This trial was a randomized, double-blind, placebo-controlled clinical trial of hormone treatment in postmenopausal women. The primary objective of PEPI was to assess the effect of unopposed estrogen and estrogen combined with cyclic or continuous progestin therapies on four different biologic/metabolic systems that are known to influence cardiovascular risk in women and believed to change with menopause or estrogen therapy. These systems were: lipid metabolism, blood pressure, carbohydrate metabolism, and coagulation/hemostasis. Secondary objectives of PEPI were to evaluate the effects of different replacement regimens on bone mineral density, endometrium, and quality of life, while also monitoring any effect on the breast. This study is a three year observational follow-up designed to monitor PEPI women for any delayed experiences by means of annual clinical visits with interim telephone contacts. Protocol: Annually on the anniversary date of their randomization into the PEPI trial, participants will be asked to attend a clinic visit. At this visit, they will receive a complete physical and pelvic examination with a Papanicolaou test and if they have a uterus, an endometrial biopsy (if a biopsy is refused or impossible to obtain, a transvaginal ultrasound evaluation will be performed). A mammogram will also be performed at this time. Height, weight, waist and hip girth, and resting blood pressure will be measured. Questionnaires will be completed assessing quality of life, physical activity, smoking and alcohol use. At the final visit (72 months after randomization into PEPI) a bone mineral density evaluation will be performed of the spine and hip. The instruments and protocols for these evaluations wil be the same as used in the PEPI study, modified as necessary to be relevant to the follow-up. An interim telephone contact will be made at 6 months after each clinic visit to ascertain any interim medication change and/or clinical illness. Participants will also be asked at this time about any intercurrent illness, any interim estrogens and progestins they have used, the reasons for any medication changes, and whether these changes were recommended or approved by their physician. Risks: The PSFS is an observational study and so has no risks associated with drug or device interventions. As part of this follow-up, participants will be asked to complete questionnaires regarding sexual functioning and moods, which they may find embarrassing or discomforting. Participants will be allowed to complete these questionnaires in a private area. Participants will also be exposed to radiation through mammograms and a bone scan. The levels of radiation exposure for these procedures is extremely low and annual mammography represents recommended clinicl treatment for women in this age group. Those women who have a uterus will also be asked to undergo an endometrial biopsy at the annual visit. The risks associated with this procedure include bleeding, pain, cramping, infection and perforation of the uterus.

基本原理：绝经后雌激素/孕激素干预（PEPI）试验包括在7个中心随访3年的875名参与者（123名参与者在霍普金斯中心随机随访）。本试验是一项绝经后妇女激素治疗的随机、双盲、安慰剂对照临床试验。PEPI的主要目的是评估非对抗性雌激素和雌激素联合周期性或连续性雌激素治疗对四种不同生物/代谢系统的影响，这些系统已知会影响女性的心血管风险，并被认为会随着绝经或雌激素治疗而改变。这些系统为：脂质代谢、血压、碳水化合物代谢和凝血/止血。PEPI的次要目的是评价不同替代方案对骨密度、子宫内膜和生活质量的影响，同时监测对乳腺的任何影响。本研究是一项为期三年的观察性随访，旨在通过每年一次的临床访视和临时电话联系来监测PEPI女性的任何延迟经历。方案：每年在随机化入组PEPI试验的周年日，要求受试者参加一次诊所访视。在这次访视中，他们将接受一次完整的身体和盆腔检查，包括巴氏试验，如果他们有子宫，则进行子宫内膜活检（如果拒绝或无法获得活检，则将进行经阴道超声评估）。此时还将进行乳房X光检查。将测量身高、体重、腰围和臀围以及静息血压。将完成对生活质量、体育活动、吸烟和饮酒的评估。在最终访视时（随机分配至PEPI后72个月），将对脊柱和髋关节进行骨密度评价。这些评价的工具和方案将与PEPI研究中使用的相同，必要时进行修改以与随访相关。在每次门诊访视后6个月进行中期电话联系，以确定任何中期药物变化和/或临床疾病。参与者还将被问及任何并发疾病，他们使用的任何临时雌激素和孕激素，任何药物变化的原因，以及这些变化是否得到他们的医生的建议或批准。风险：PSFS是一项观察性研究，因此没有与药物或器械干预相关的风险。作为后续行动的一部分，参与者将被要求完成有关性功能和情绪的问卷，他们可能会感到尴尬或不安。参与者将被允许在一个私人区域完成这些问卷。参与者还将通过乳房X光检查和骨骼扫描接受辐射。这些程序的辐射暴露水平极低，每年的乳房X光检查是该年龄组女性的推荐临床治疗。那些有子宫的妇女也将被要求在每年的访视中接受子宫内膜活检。与该手术相关的风险包括出血、疼痛、痉挛、感染和子宫穿孔。