Bioidentical Hormone Replacement Therapy in Postmenopausal Women

Not yet recruiting

• Conditions: Hormon Replacement Terapy

• Registration Number: NCT07163442
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-09-20
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 107

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...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bone mineral densitometry	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 Outcome Measures

Name	Time	Method
mammography report	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.