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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06975111
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Cardiovascular
  • Menopause
  • Menopause Hot Flashes
  • Menopause Related Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin — DRUG
    Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
  • semaglutide — DRUG
    Overweight women and women with obesity will take Semaglutide for weight-loss
  • Anti-hypertensives — DRUG
    a. Antihypertensives, with the goal of maintaining blood pressure at 130/80 or lower per ACC guidelines19. Per current clinical guidelines and standard of care, hypertension will be treated first with monotherapy using either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic provided that are no contraindications.
  • Lipid Lowering Medication — DRUG
    . First line agents will be generic statin medications (atorvastatin or rosuvastatin)whichever is covered by the participant's health insurance), barring contraindication to their use.
  • Life style intervention — BEHAVIORAL
    will simply be followed and given preventive advice (maintenance of a normal BMI and physical activity, moderation in salt intake, and no more than 1 alcoholic drink per day). They will be provided with a wearable activity monitor. This advice will be based on guidelines by the American Heart Association and the Menopause Society.
  • Fezolinetant — DRUG
    Women with menopausal symptoms will be treated with hormone therapy (estrogen and progesterone) if appropriate, or with a neurokinin receptor antagonist (Fezolinetant). This can be treatment for women in any arm of the study as well as an arm by its self.
  • Hormonal therapy — DRUG
    Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.

Study Details

What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.

Key Dates

Start date
Mar 1, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2029
Completion
Oct 1, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Preventative Health Advice
    Participants will be given preventative health advice and asked to wear an activity \& sleep monitor.
  • Active Comparator: At Risk for Heart Disease
    Medications will be given to each participant in this arm that lowers your heart disease risk.
  • Active Comparator: Overweight Women
    Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.
  • Active Comparator: Women with Obesity
    Women that are over a BMI of 30 kg/m2 will be offered a GLP-1 antagonist.
  • Active Comparator: Women With Hot Flashes
    Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and/or severity of hot flashes.

Primary Outcome Measure

Epigenetic aging measurements of "PhenoAge" [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado-School of MedicineAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Menopause
By specialty
Women's healthFertility
By research site
University of Colorado-School of Medicine· Aurora, CO

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