Perimenopausal BiomarkersNCT06852755
Development of Biomarkers for Monitoring Menopause in Women
An observational study of Perimenopausal Biomarkers and Mitochondrial Biomarkers, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
This cross-sectional study aims to develop and validate mitochondrial biomarkers for monitoring menopause in women. The study will involve 100 participants divided into three groups: reproductive period, perimenopausal transition period, and postmenopausal period. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Biomarkers, Mitochondrial Biomarkers
- What is being tested?
- Blood Sample Collection
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Population Description: The study population consists of adult women aged over 20 years old, categorized into three groups: reproductive period (ages 20-45, regular menstrual cycles) perimenopausal transition period (ages 45-50, experiencing menstrual irregularities) postmenopausal period (ages over 50, no menstrual period for at least one year). All participants must be in general good health, without major chronic diseases, infection, or pregnancy.
Who may be able to join
- Biological female, age order than 20 years old.
Who cannot join
- Person with cancer.
- Person with any known acute or chronic infection.
- Person with known chronic illness under follow up or treatment.
- Pregnancy, one year withing delivery, under breast feeding, or three months within breast feeding.
- Under any female horemone therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Shu-Yu Liu, +886910893512, syliu0123@outlook.com
About this study
This cross-sectional study aims to develop and validate mitochondrial biomarkers for monitoring menopause in women. The study will involve 100 participants divided into three groups: reproductive period, perimenopausal transition period, and postmenopausal period. Peripheral blood samples will be collected, and mitochondrial quality and quantity will be assessed using both qualitative and quantitative analyses. The study will identify potential biomarkers through metabolomics and validate them for monitoring the perimenopausal transition, providing a novel approach for women's health management during menopause.
Read the detailed description
Background： Gender equality and equitable health have emerged as international trends in recent years. Despite existing solutions for women's health issues, many needs remain unmet. According to projections, the global menopausal population is expected to reach 1.2 billion by 2030, surpassing the prevalence of the most common chronic diseases. Presently, solutions exist for common menopausal symptoms such as hot flashes, night sweats, fatigue, irritability, and urinary incontinence. However, unresolved challenges encompass psychological changes and monitoring systems. Therefore, this project aims to develop biomarkers for menopause in women as a future monitoring system.
Most women enter menopause between the ages of 48 and 52. During this period, ovarian follicles cease activity, leading to the one-year period following the appearance of significant menstrual irregularities, known as the menopausal transition or perimenopause (1). As ovarian function gradually declines and estrogen secretion diminishes, various systemic changes occur, resulting in several menopause-related conditions such as osteoporosis, cardiovascular diseases, and urinary system issues. The decline in estrogen triggers a negative feedback loop, causing an increase in follicle-stimulating hormone (FSH) secretion and a reduction in E2 (17β-estradiol) production (2). Currently, menopausal hormone therapy (MHT) using estrogen can alleviate menopausal symptoms and restore overall E2 levels but doesn't lower FSH to premenopausal levels (3-4). However, a precise biomarker for monitoring menopause has not yet been established. Under estrogen deficiency, mitochondrial morphology and function may be compromised, while estrogen presence relates to reduced oxidative reactions, enhanced respiratory function, and stable membrane properties (5). This project aims to provide a comprehensive view through metabolomics to identify biomarkers within mitochondria that can be used for menopause monitoring.
Study Design： This study is a cross-sectional study. A total of 100 women will be included and grouped into three categories: 25 cases of reproductive period, 50 cases of perimenopausal transition period, and 25 cases of postmenopausal period. The peripheral blood will be collected. Following mitochondrial extraction, both qualitative and quantitative analyses are conducted. High-confidence protein markers are identified as candidate molecules using combined data from RNA-seq and LC/MS/MS. These candidate markers will undergo further validation testing.
Methods： After Ficoll separation, peripheral blood will be divided into mononuclear cells, plasma, and red blood cells. Further extraction of mitochondria will be carried out from both mononuclear cells and plasma. Quantitative experiments involve hippocampal measurements of metabolic energy and JC-1 assessment of mitochondrial health, while mitochondrial DNA copy number will be evaluated using digital PCR. Qualitative experimental analysis employs Western blotting to assess markers such as cytochrome c and HSP60 for mitochondria and PCNA for nuclear proteins. Candidate biomarker validation experiments use combined data from RNA-seq and LC/MS/MS to identify high-confidence protein markers as candidates, which are further validated for feasibility using the ELISA method.
Effect：
- Understand the changes in mitochondrial quality and quantity during the perimenopausal transition in women.
- Develop monitoring indicators for the perimenopausal transition in women.
- Being tested
- Blood Sample Collection
- Keywords
- Perimenopausal Transition, Mitochondria, Biomarker, Women's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
Collection of peripheral blood samples for mitochondrial analysis, including the extraction of mononuclear cells and plasma for further assessment of mitochondrial quality and quantity.
| Study group | Role | What they receive |
|---|---|---|
| Reproductive Period | Women aged 20-40 years with regular menstrual cycles, representing the reproductive stage. Receives: Other: Blood Sample Collection | |
| Perimenopausal Transition Period | Women aged 40-55 years have menstrual cycle within one year but experiencing menstrual irregularities, representing the transition into menopause. Receives: Other: Blood Sample Collection | |
| Postmenopausal Period | Women aged 50 years and older who have not had a menstrual period for at least one year, representing the postmenopausal stage. Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial Quantitative Analysis
This outcome measure involves evaluating mitochondrial energy metabolism, including ATP content, oxygen consumption rate (OCR), and extracellular acidification rate (ECAR) using a hippocampal metabolic analyzer. Additionally, mitochondrial membrane potential will be assessed using flow cytometry to analyze the distribution of JC-1, indicating mitochondrial health. Digital PCR will be employed to measure mitochondrial DNA copy numbers, determining mitochondrial mass and comparing differences between groups.
Measured: 12 months from study start
Mitochondrial Qualitative Analysis
This measure assesses mitochondrial protein markers using Western blot analysis. PCNA will be used as a nuclear protein marker, while cytochrome c and HSP60 will be used as mitochondrial protein markers to evaluate mitochondrial quality
Measured: 12 months from study start
Validation of Candidate Biomarkers
This outcome measure focuses on the validation of high-confidence protein markers identified through RNA-Seq and LC-MS/MS data. The validation will be conducted using customized protein databases and further experiments to confirm the feasibility of these candidate biomarkers for monitoring perimenopausal transition.
Measured: 12 months from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start30 Jul 2024
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perimenopausal BiomarkersStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852755
- Sponsor's protocol ID
- FJUH112331
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, Santoro N, Simoncini T. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. doi: 10.1038/nrdp.2015.4.
PubMed 27188659Pellegrino A, Tiidus PM, Vandenboom R. Mechanisms of Estrogen Influence on Skeletal Muscle: Mass, Regeneration, and Mitochondrial Function. Sports Med. 2022 Dec;52(12):2853-2869. doi: 10.1007/s40279-022-01733-9. Epub 2022 Jul 30.
PubMed 35907119Karppinen JE, Tormakangas T, Kujala UM, Sipila S, Laukkanen J, Aukee P, Kovanen V, Laakkonen EK. Menopause modulates the circulating metabolome: evidence from a prospective cohort study. Eur J Prev Cardiol. 2022 Aug 5;29(10):1448-1459. doi: 10.1093/eurjpc/zwac060.
PubMed 35930503Powers MS, Schenkel L, Darley PE, Good WR, Balestra JC, Place VA. Pharmacokinetics and pharmacodynamics of transdermal dosage forms of 17 beta-estradiol: comparison with conventional oral estrogens used for hormone replacement. Am J Obstet Gynecol. 1985 Aug 15;152(8):1099-106. doi: 10.1016/0002-9378(85)90569-1.
PubMed 2992279
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biomarkers for Monitoring Menopause in Women
- ClinicalTrials.gov ID
- NCT06852755
- Acronym / sponsor ID
- FJUH112331
- Keywords
- Perimenopausal Transition, Mitochondria, Biomarker, Women's Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Feb 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.
This cross-sectional study aims to develop and validate mitochondrial biomarkers for monitoring menopause in women. The study will involve 100 participants divided into three groups: reproductive period, perimenopausal transition period, and postmenopausal period. Peripheral blood samples will be collected, and mitochondrial quality and quantity will be assessed using both qualitative and quantitative analyses. The study will identify potential biomarkers through metabolomics and validate them for monitoring the perimenopausal transition, providing a novel approach for women's health management during menopause.
Detailed description
Background： Gender equality and equitable health have emerged as international trends in recent years. Despite existing solutions for women's health issues, many needs remain unmet. According to projections, the global menopausal population is expected to reach 1.2 billion by 2030, surpassing the prevalence of the most common chronic diseases. Presently, solutions exist for common menopausal symptoms such as hot flashes, night sweats, fatigue, irritability, and urinary incontinence. However, unresolved challenges encompass psychological changes and monitoring systems. Therefore, this project aims to develop biomarkers for menopause in women as a future monitoring system.
Most women enter menopause between the ages of 48 and 52. During this period, ovarian follicles cease activity, leading to the one-year period following the appearance of significant menstrual irregularities, known as the menopausal transition or perimenopause (1). As ovarian function gradually declines and estrogen secretion diminishes, various systemic changes occur, resulting in several menopause-related conditions such as osteoporosis, cardiovascular diseases, and urinary system issues. The decline in estrogen triggers a negative feedback loop, causing an increase in follicle-stimulating hormone (FSH) secretion and a reduction in E2 (17β-estradiol) production (2). Currently, menopausal hormone therapy (MHT) using estrogen can alleviate menopausal symptoms and restore overall E2 levels but doesn't lower FSH to premenopausal levels (3-4). However, a precise biomarker for monitoring menopause has not yet been established. Under estrogen deficiency, mitochondrial morphology and function may be compromised, while estrogen presence relates to reduced oxidative reactions, enhanced respiratory function, and stable membrane properties (5). This project aims to provide a comprehensive view through metabolomics to identify biomarkers within mitochondria that can be used for menopause monitoring.
Study Design： This study is a cross-sectional study. A total of 100 women will be included and grouped into three categories: 25 cases of reproductive period, 50 cases of perimenopausal transition period, and 25 cases of postmenopausal period. The peripheral blood will be collected. Following mitochondrial extraction, both qualitative and quantitative analyses are conducted. High-confidence protein markers are identified as candidate molecules using combined data from RNA-seq and LC/MS/MS. These candidate markers will undergo further validation testing.
Methods： After Ficoll separation, peripheral blood will be divided into mononuclear cells, plasma, and red blood cells. Further extraction of mitochondria will be carried out from both mononuclear cells and plasma. Quantitative experiments involve hippocampal measurements of metabolic energy and JC-1 assessment of mitochondrial health, while mitochondrial DNA copy number will be evaluated using digital PCR. Qualitative experimental analysis employs Western blotting to assess markers such as cytochrome c and HSP60 for mitochondria and PCNA for nuclear proteins. Candidate biomarker validation experiments use combined data from RNA-seq and LC/MS/MS to identify high-confidence protein markers as candidates, which are further validated for feasibility using the ELISA method.
Effect：
- Understand the changes in mitochondrial quality and quantity during the perimenopausal transition in women.
- Develop monitoring indicators for the perimenopausal transition in women.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reproductive Period | – | Other: Blood Sample CollectionWomen aged 20-40 years with regular menstrual cycles, representing the reproductive stage. |
| Perimenopausal Transition Period | – | Other: Blood Sample CollectionWomen aged 40-55 years have menstrual cycle within one year but experiencing menstrual irregularities, representing the transition into menopause. |
| Postmenopausal Period | – | Other: Blood Sample CollectionWomen aged 50 years and older who have not had a menstrual period for at least one year, representing the postmenopausal stage. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population Description: The study population consists of adult women aged over 20 years old, categorized into three groups: reproductive period (ages 20-45, regular menstrual cycles) perimenopausal transition period (ages 45-50, experiencing menstrual irregularities) postmenopausal period (ages over 50, no menstrual period for at least one year). All participants must be in general good health, without major chronic diseases, infection, or pregnancy.
Key inclusion criteria (1 listed)
- Biological female, age order than 20 years old.
Key exclusion criteria (5 listed)
- Person with cancer.
- Person with any known acute or chronic infection.
- Person with known chronic illness under follow up or treatment.
- Pregnancy, one year withing delivery, under breast feeding, or three months within breast feeding.
- Under any female horemone therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionCollection of peripheral blood samples for mitochondrial analysis, including the extraction of mononuclear cells and plasma for further assessment of mitochondrial quality and quantity. | Other | Perimenopausal Transition Period, Postmenopausal Period, Reproductive Period |
Primary outcome
Mitochondrial Quantitative Analysis
Time frame: 12 months from study start
This outcome measure involves evaluating mitochondrial energy metabolism, including ATP content, oxygen consumption rate (OCR), and extracellular acidification rate (ECAR) using a hippocampal metabolic analyzer. Additionally, mitochondrial membrane potential will be assessed using flow cytometry to analyze the distribution of JC-1, indicating mitochondrial health. Digital PCR will be employed to measure mitochondrial DNA copy numbers, determining mitochondrial mass and comparing differences between groups.
Mitochondrial Qualitative Analysis
Time frame: 12 months from study start
This measure assesses mitochondrial protein markers using Western blot analysis. PCNA will be used as a nuclear protein marker, while cytochrome c and HSP60 will be used as mitochondrial protein markers to evaluate mitochondrial quality
Validation of Candidate Biomarkers
Time frame: 12 months from study start
This outcome measure focuses on the validation of high-confidence protein markers identified through RNA-Seq and LC-MS/MS data. The validation will be conducted using customized protein databases and further experiments to confirm the feasibility of these candidate biomarkers for monitoring perimenopausal transition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 27188659Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, Santoro N, Simoncini T. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. doi: 10.1038/nrdp.2015.4.
- Background: PubMed 35907119Pellegrino A, Tiidus PM, Vandenboom R. Mechanisms of Estrogen Influence on Skeletal Muscle: Mass, Regeneration, and Mitochondrial Function. Sports Med. 2022 Dec;52(12):2853-2869. doi: 10.1007/s40279-022-01733-9. Epub 2022 Jul 30.
- Background: PubMed 35930503Karppinen JE, Tormakangas T, Kujala UM, Sipila S, Laukkanen J, Aukee P, Kovanen V, Laakkonen EK. Menopause modulates the circulating metabolome: evidence from a prospective cohort study. Eur J Prev Cardiol. 2022 Aug 5;29(10):1448-1459. doi: 10.1093/eurjpc/zwac060.
- Background: PubMed 2992279Powers MS, Schenkel L, Darley PE, Good WR, Balestra JC, Place VA. Pharmacokinetics and pharmacodynamics of transdermal dosage forms of 17 beta-estradiol: comparison with conventional oral estrogens used for hormone replacement. Am J Obstet Gynecol. 1985 Aug 15;152(8):1099-106. doi: 10.1016/0002-9378(85)90569-1.
- Individual participant dataSharing planned: No
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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.
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 Perimenopausal Biomarkers and Mitochondrial Biomarkers, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 May 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu-Yu Liu (+886910893512, syliu0123@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial Quantitative Analysis (time frame: 12 months from study start). The study lists 3 primary outcomes in all. 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 NCT06852755, which also lists 4 linked publications.
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 25 May 2025.