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Completed

NCT Number: NCT07163442

Bioidentical Hormone Replacement Therapy in Postmenopausal Women

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.

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Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Gaziosmanpaşa Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. bone mineral densitometry

    Time frame: 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.

Secondary outcomes

  1. mammography report

    Time frame: From enrollment to the end of treatment at one-year"

    B-RADS scores will be obtained from patients' mammography reports. This score ranges from 0 to 5.

    Category 0: Additional imaging is needed. Category 1: Normal findings. Category 2: Definitely benign findings. Category 3: Probably benign findings. Category 4: Suspicious findings. Category 5: High probability of malignant findings.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.