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Scalp Hair Estradiol and Progesterone Level Determination in Women (Proof of Concept Study)

2016年4月26日 更新者:samer.khoury、Bnai Zion Medical Center

Scalp Hair Estradiol and Progesterone Level Determination in Pre-menopausal and Post-menopausal Women (Proof of Concept Study)

The investigators hypothesis is that we can determine estrogen and progesterone levels in the hair by using the immune method and we can show a significant difference in the levels of these hormones in both groups of women: pre- and postmenopausal women. If indeed it would then be possible in future to carry out research that can find a relationship between the levels of these hormones and various diseases

研究概览

地位

未知

条件

详细说明

One group will include 20 women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.

From all of the participants the investigators will collect hair samples at the crown back of the head (hair will be cut as close as possible to the scalp), the samples will be measured quantitatively about 100 hairs at a length of 2-3 cm. In order to grind the hair samples we will use a mini-Bead beater machine. milled hairs will be incubated overnight in a solution of 1 ml methanol 50, in constant gentle muddling. Afterwards, ethanol will disperse through a stream of nitrogen. The remainder of the suspension will be dissolved at 200 microliter buffer PBS (Phosphate-Buffered Saline) (pH 8.0) and the concentration of estrogen and progesterone will be measured by using the immune method which is available in the endocrine laboratory in Bnai Zion medical center. At the end of the study the investigators will cary out a statistical comparison of progesterone and estrogen levels between the two groups.

研究类型

观察性的

注册 (预期的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

One group will include 20 women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.

描述

Inclusion Criteria:

  • women under 40 with regular cycles
  • Women over the age of 60 in menopause for at least 5 years

Exclusion Criteria:

  • pregnant women
  • oral contraceptive treatment in the last year
  • hormonal replacement therapy in the last year
  • 6 month after delivery
  • infertile women
  • irregular menstruation
  • women with progesterone secretion intrauterine device in the last year
  • BMI- Body Mass Index- below 25 or above 35
  • Polycystic Ovarian Syndrome
  • steriodal treatment including inhalers and ointments.
  • status post Removal of the ovaries or uterus
  • Breast or uterine cancer in the past.
  • any pituitary or adrenal disease

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
premenopausal and postmenopausal women
One group will include 20 premenopausal women under the age 40 years old, with regular menstruation cycles and without any illness or medication including birth control pills or steroidal ointments, and without known diagnosis of polycystic ovaries or fertility disorder. The second group will include 20 postmenopausal women over the age of 60, with no menstruation at least for the last five years, and without hormone therapy or treatment of any Steroidal therapy for the last year.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
concentration of hair scalp progesterone
大体时间:3 months
concentration of hair scalp progesterone (nmol\L)
3 months
concentration of hair scalp estrogen
大体时间:3 months
concentration of hair scalp estrogen (pmol\L)
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:samer khoury、Bnai Zion Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年3月1日

初级完成 (预期的)

2017年1月1日

研究完成 (预期的)

2017年3月1日

研究注册日期

首次提交

2016年4月19日

首先提交符合 QC 标准的

2016年4月26日

首次发布 (估计)

2016年4月28日

研究记录更新

最后更新发布 (估计)

2016年4月28日

上次提交的符合 QC 标准的更新

2016年4月26日

最后验证

2016年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • BNZ160015CTIL

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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