What this trial studies
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.
Conditions in scope
- Perimenopausal Biomarkers
- Mitochondrial Biomarkers
Interventions
- Blood Sample Collection (Other) — Collection of peripheral blood samples for mitochondrial analysis, including the extraction of mononuclear cells and plasma for further assessment of mitochondrial quality and quantity.
Who can join
Women only · Ages 20 Years and up · Accepts healthy volunteers.
Inclusion criteria
- Biological female, age order than 20 years old.
Exclusion criteria
- 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 wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| New Taipei City | Fu Jen Catholic University Hospital, Fu Jen Catholic University | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Observational
- Phase: N/A
- Start date: 2024-07-30
- Primary completion: 2026-02
- Last update posted: 2025-05-25
- First posted: 2025-02-28
Sponsor & contact
Lead sponsor: Fu Jen Catholic University Hospital (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Mitochondrial Quantitative Analysis (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… - Mitochondrial Qualitative Analysis (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 (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.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06852755 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.