Recruiting
Phase 2
Phase 3

Health Interventions

Sponsor:

University of Colorado, Denver

Code:

NCT06975111

Conditions

Menopause

Menopause Hot Flashes

Menopause Related Conditions

Cardiovascular

Eligibility Criteria

Sex: Female

Age: 45 - 55

Healthy Volunteers: Accepted

Interventions

Metformin

semaglutide

Anti-hypertensives

Lipid Lowering Medication

Life style intervention

Study Details

Brief 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

Study ID

NCT06975111

Start date

Mar 1, 2026

Status verified date

Jul, 2026

Completion date

Oct 1, 2030

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Metformin

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

semaglutide

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

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.

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.

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.

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.

Hormonal therapy

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Carrie Hsu, BA

303-724-5276carrie.hsu@cuanschutz.edu

Nalia Naushad

naila.naushad@cuanschutz.edu

Locations

University of Colorado-School of Medicine

Recruiting

Aurora, Colorado, United States, 80045

University of North Carolina, School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Chelsea A Grinnan, RN

919-908-0010REI_research@med.unc.edu

Makayla L Sweeney, BSc

919-908-0010REI_research@med.unc.edu

Principal Investigator:

Genevieve Neal-Perry, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Keila Najera, MPH

804-221-5159Keila.najera@vcuhealth.org

Michelle Orr, PhD, RN

804-221-5159Keila.najera@vcuhealth.org

Principal Investigator:

Samar El Khoudary, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-07-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.