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

Summary

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.

Conditions

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

Interventions

DRUG

Metformin

Metformin will be given to participants who have a elevated HbA1c and also for weightloss.

DRUG

semaglutide

Overweight women and women with obesity will take Semaglutide for weight-loss

DRUG

Anti-hypertensives

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.

DRUG

Lipid Lowering Medication

. 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.

BEHAVIORAL

Life style intervention

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.

DRUG

Fezolinetant

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.

DRUG

Hormonal therapy

Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.

Sponsors & Collaborators

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Nanette Santoro, MD · University of Colorado, Denver

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2029-10-31

Completion

2030-10-01

FDA Drug

Yes

Countries

• United States

Study Locations