Hormon Replacement TerapyNCT07163442
Bioidentical Hormone Replacement Therapy in Postmenopausal Women
An observational study of Hormon Replacement Terapy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Hormon Replacement Terapy
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2025to 30 Oct 2025
- How long will I take part?
- 107 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been in menopause for at least 1 year and do not have endocrine or metabolic disorders that alter hormone levels.
Who may be able to join
- Being in menopause for a year
- being on hormone replacement therapy
Who cannot join
- taking HRT in addition to the drugs monitored in the study
- having a hormone-secreting endocrine disorder
- having endocrine cancer(breast cancer...)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Education and Research Hospital
Istanbul
About this study
Official title: One-year Results of 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.
Read the 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
- Conditions
- Hormon Replacement Terapy
- Keywords
- post-menopausal, hormone replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| grup:1 group not taking postmenopausal hormones | postmenopausal women who have been in menopause for at least 1 year and have not taken any hormone supplements | |
| grup 2: Patients who have been receiving HRT for 1 year | Patients who have been using HRT for at least 1 year since the onset of menopause |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral densitometry
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.
Measured: From enrollment to the end of treatment at one-year"
Secondary outcomes (1)
mammography report
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.
Measured: From enrollment to the end of treatment at one-year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start20 Oct 2025
- Primary completion20 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormon Replacement TerapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
- Target duration
- 107 Days
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Yıldız, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163442
- Sponsor's protocol ID
- GaziosmanpasatrehmENA
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No: There is not a plan to make IPD available.
Publications
Kissinger D. Hormone replacement therapy perspectives. Front Glob Womens Health. 2024 May 20;5:1397123. doi: 10.3389/fgwh.2024.1397123. eCollection 2024.
PubMed 38832110
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Results of Bioidentical Hormone Replacement Therapy in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07163442
- Acronym / sponsor ID
- GaziosmanpasatrehmENA
- Conditions
- Hormon Replacement Terapy
- Keywords
- post-menopausal, hormone replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 107 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grup:1 group not taking postmenopausal hormones | – | –postmenopausal women who have been in menopause for at least 1 year and have not taken any hormone supplements |
| grup 2: Patients who have been receiving HRT for 1 year | – | –Patients who have been using HRT for at least 1 year since the onset of menopause |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been in menopause for at least 1 year and do not have endocrine or metabolic disorders that alter hormone levels.
Key inclusion criteria (2 listed)
- Being in menopause for a year
- being on hormone replacement therapy
Key exclusion criteria (3 listed)
- taking HRT in addition to the drugs monitored in the study
- having a hormone-secreting endocrine disorder
- having endocrine cancer(breast cancer...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
mammography report
Time frame: From enrollment to the end of treatment at one-year"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 38832110Kissinger D. Hormone replacement therapy perspectives. Front Glob Womens Health. 2024 May 20;5:1397123. doi: 10.3389/fgwh.2024.1397123. eCollection 2024.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormon Replacement Terapy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral densitometry (time frame: From enrollment to the end of treatment at one-year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.