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NCT06975111PHASE2, PHASE3RecruitingAccepts Healthy Volunteers

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

University of Colorado, Denver

Start Date

3/1/2026

Completion Date

10/1/2030

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.

Eligibility Criteria

Age Range: 45 years to 55 years

Inclusion Criteria: * 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 Criteria: * 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.

Interventions

DRUG

Metformin

DRUG

semaglutide

DRUG

Anti-hypertensives

DRUG

Lipid Lowering Medication

BEHAVIORAL

Life style intervention

DRUG

Fezolinetant

DRUG

Hormonal therapy

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Conditions

MenopauseMenopause Hot FlashesMenopause Related ConditionsCardiovascular

Locations

University of Colorado-School of Medicine

Aurora, Colorado 80045

United States

University of North Carolina, School of Medicine

Chapel Hill, North Carolina 27599

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States