NCT06975111

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-10-31
• Completion: 2030-10-01
• First posted: 2025-05-16
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study