Convergent Mechanisms Underlying Reprometabolic Syndrome in Women and Sheep
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Amount of Luteinizing hormone Surge
研究概览
简要总结
Dr. Nanette Santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. This will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.
详细描述
This is an open-label, single site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of normal BMI or high BMI. The objective of the study is to determine the effects of an estradiol patch on luteinizing hormone rise in both cohorts. The study consists of 2 periods: a screening period of up to 3 weeks and a Treatment Period of 7-10 days. During the treatment period participants will wear estradiol patches for up to 7 days and have on blood draw on day 3 of wearing the patches. Participants will also collect daily morning urine for all the days they wear the patches. Participants will use a reliable barrier method of birth control or abstain from intercourse for the duration of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-38
- •Regular menstrual cycles every 25-35 days
- •No use of reproductive hormones within the past 3 months
- •No use of medications interacting with reproductive hormones
- •Agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study
- •Normal thyroid stimulating hormone, prolactin and lipid profiles
- •No more than 4 hours of moderate to vigorous intensity exercise per week
- •No history of chronic disease impacting reproductive hormones
- •No contraindications to administration of estradiol
- •No history of estrogen dependent cancer
- •Negative pregnancy test
排除标准
- •Has diabetes
- •Is a smoker
- •History of venous thromboembolism or known thrombophilia
研究组 & 干预措施
Estradiol Patch- Normal Weight women
Normal weight women (NWW) will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
干预措施: Estradiol Patches (Drug)
Estradiol Patch- Women with high BMI
Women with a BMI greater than 30 kg/m2 will wear a Transdermal estradiol patch for 7 days and collect urine to determine LH surge.
干预措施: Estradiol Patches (Drug)
结局指标
主要结局
Amount of Luteinizing hormone Surge
时间窗: From enrollment to the end of treatment is 7 days.
Urinary luteinizing hormone concentration in mIU/mg of Creatinine
次要结局
- Time of Luteinizing Hormone Peak(From enrollment to 7 days)