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
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