Improving Mid-Life Women's Health During Menopause Transition

This study is exploring whether a combination of existing health interventions can improve the health of women transitioning through menopause. Researchers are looking at how these interventions might reduce inflammation, improve heart health, and potentially reverse 'epigenetic aging' (changes to your DNA that happen over time). The interventions include medications like metformin (for elevated blood sugar and weight loss), semaglutide (for weight loss), anti-hypertensives (for high blood pressure), and lipid-lowering medications (for high cholesterol). Participants will also receive lifestyle advice and a wearable activity monitor. The study aims to enhance quality of life and extend health for women aged 45-55 who are in the late menopausal transition, have not used hormone therapy recently, and have a smartphone.

Study design
This is an interventional study with a planned enrollment of 200 women. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to measure changes in epigenetic aging.

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NCT06975111

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

Recruiting
PHASE2Ages 45–55InterventionalTreatment
University of Colorado, Denver
~200 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:MetforminsemaglutideAnti-hypertensivesLipid Lowering MedicationLife style interventionFezolinetant

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Epigenetic aging measurements of "PhenoAge"
Measured over Up to 2 years
+1 more outcome measured
Menopause
Menopause Hot Flashes
Menopause Related Conditions
Cardiovascular
3 sites across 3 states
Colorado1
North Carolina1
Virginia1
  • Nanette Santoro, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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Eligibility criteria

Inclusion

aged 45-55
In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18
No current use of hormone therapy or hormonal contraception
Presence of a uterus and at least one ovary in order to track menstrual patterns
Have a smartphone and broadband access adequate to accept telehealth appointments

Exclusion

Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)
Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant.
Pregnancy or actively trying to get pregnant
Inability to adhere to study protocol schedule
Untreated alcoholism
Un- Diagnosed abnormal uterine bleeding
Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\> 30 kg/m2.
  • Epigenetic aging measurements of "PhenoAge"Up to 2 years

    Change in epigenetic aging, as assessed by PhenoAge. PhenoAge calculates a biological age score based on key biomarkers circulating in the bloodstream. A lower PhenoAge score suggests slower biological aging, while a higher score indicates accelerated aging.

  • Epigenetic aging measurements of "GrimAge"Up to 2 years

    Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.