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Bioidentical Hormone Replacement Therapy in Postmenopausal Women

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07163442
Enrollment
107
Registered
2025-09-09
Start date
2025-10-20
Completion date
2025-10-30
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormon Replacement Terapy

Keywords

post-menopausal, hormone replacement

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

Interventions

None listed

Sponsors

Gaziosmanpasa Research and Education Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frameDescription
bone mineral densitometryFrom enrollment to the end of treatment at one-yearIn 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

MeasureTime frameDescription
mammography reportFrom enrollment to the end of treatment at one-yearB-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026