Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Changes in Prefrontal cortex brain activation
研究概览
简要总结
Complaints about memory and thinking are common in women as they go through menopause. The female hormone estrogen is important for both the health of both the brain and the blood vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study will look at how the loss of the female hormone estrogen affects brain function and the health of blood vessels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Stages of Reproductive Aging Workshop (STRAW+10) peak or late reproductive stage (-4, -3b or -3a)
- •Healthy based on medical history, physical examination and standard blood chemistries
- •Normotensive (resting blood pressure <140/90 mmHg)
- •Normoglycemia (fasting glucose <110mg/dl and hemoglobin A1c<6.5%)
- •Non-smoker (for at least 12 months)
排除标准
- •Serum Follical Stimulating Hormone (FSH) >25mIU/mL measured during the first 5 days of the menstrual cycle
- •Use of hormonal therapy within the past 3 months
- •Use of antihypertensive or lipid-lowering medications
- •Pregnant or lactating, or planning to become pregnant during the study period
- •Known hypersensitivity to any of the study medications
- •Abnormal vaginal bleeding
- •History of venous thromboembolism or hormone-sensitive cancer
- •History of neurologic disease or major psychiatric illness
- •History of diagnosed learning disability or less than high-school education
- •Contraindication to Magnetic Resonance Imaging (MRI) scanning
- •Depression (Center for Epidemiological Studies - Depression (CESD) score >16)
- •Significant cognitive impairment (Mini Mental State Examination (MMSE) score <27)
- •Severe osteopenia or osteoporosis (proximal femur or lumbar spine T-score < -2.0)
- •Body Mass Index (BMI) >40kg/m2
研究组 & 干预措施
GnRHant + Placebo
Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal placebo patch, weekly for 12 weeks
干预措施: GnRHant + Placebo (Other)
GnRHant + E2
Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal estradiol add-back; Climara patch, 0.075mg/day, weekly for 12 weeks
干预措施: GnRHant + E2 (Other)
结局指标
主要结局
Changes in Prefrontal cortex brain activation
时间窗: Baseline, 3 months
Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline and 3 months
次要结局
- Changes in Endothelial function(Baseline, 3 months)
- Changes in Arterial stiffness(Baseline, 3 months)
- Changes in Executive cognitive function(Baseline, 3 months)