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临床试验/NCT07163442
NCT07163442已完成不适用

One-year Results of Bioidentical Hormone Replacement Therapy in Postmenopausal Women

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2025年10月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
1
主要终点
bone mineral densitometry

研究概览

简要总结

The aim of this observational study is to investigate the effects of bioidentical HRT over a 1-year period in postmenopausal women receiving transdermal estradiol and, when necessary, progesterone. The main question the study aims to answer is:

Does bioidentical hormone replacement therapy, when used long-term in postmenopausal women, reduce the negative effects of menopause compared to women who do not receive it? Participants who were already receiving bioidentical transdermal estradiol and micro-dose progesterone as part of their regular medical care under postmenopausal hormone therapy were compared to a group not receiving such therapy over a one-year period, with measurements taken of bone densitometry, mammography, blood lipid parameters (HDL, LDL, VLDL, total cholesterol), and HbA1c levels.

详细描述

The aim of this observational study is to investigate the effects of bioidentical HRT over a 1-year period in postmenopausal women receiving transdermal estradiol and, when necessary, progesterone. The main question the study aims to answer is:

Does bioidentical hormone replacement therapy, when used long-term in postmenopausal women, reduce the negative effects of menopause compared to women who do not receive it? Participants who were already receiving bioidentical transdermal estradiol and micro-dose progesterone as part of their regular medical care under postmenopausal hormone therapy were compared to a group not receiving such therapy over a 1-year period, with measurements taken of bone densitometry, mammography, blood lipid parameters (HDL, LDL, VLDL, total cholesterol), and HbA1c levels. Additionally, they were asked to complete a questionnaire aimed at assessing the severity of vasomotor symptoms during menopause. The patients were divided into two groups. Group 1 consisted of women who had been in menopause for one year and had never taken HRT, while Group 2 consisted of women who had been in menopause for one year or more and were using transdermal bioidentical HRT and micronized progesterone. The values of these two groups were compared to evaluate the effect of HRT

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being in menopause for a year
  • being on hormone replacement therapy

排除标准

  • taking HRT in addition to the drugs monitored in the study
  • having a hormone-secreting endocrine disorder
  • having endocrine cancer(breast cancer...)

结局指标

主要结局

bone mineral densitometry

时间窗: From enrollment to the end of treatment at one-year"

In bone mineral densitometry, the T and Z scores of the left femur and spine will be examined. Values above -1.5 are considered normal, values between -1.5 and -2.5 indicate osteopenia, and values below -2.5 indicate osteoporosis.

次要结局

  • mammography report(From enrollment to the end of treatment at one-year")

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Elif Yıldız

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Gaziosmanpasa Research and Education Hospital

研究点 (1)

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