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NCT Number: NCT06975111

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

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.

Recruiting

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Key information

Conditions

Menopause Cardiovascular Menopause Hot Flashes Menopause Related Conditions

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Colorado-School of Medicine, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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

semaglutide

Drug

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

Anti-hypertensives

Drug

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.

Other names: The use of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic.

Lipid Lowering Medication

Drug

. 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.

Other names: The use of generic statins

Life style intervention

Behavioral

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

Drug

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

Drug

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

Primary outcomes

  1. Epigenetic aging measurements of "PhenoAge"

    Time frame: Up to 2 years

    Change in epigenetic aging, as assessed by PhenoAge. PhenoAge calculates a biological age score based on key biomarkers circulating in the bloodstream. A lower PhenoAge score suggests slower biological aging, while a higher score indicates accelerated aging.

  2. Epigenetic aging measurements of "GrimAge"

    Time frame: Up to 2 years

    Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.

Secondary outcomes

  1. IL-1

    Time frame: Up to 2 years

    Inflammatory IL-1 serum levels, examined to determine a person's inflammatory state. Higher levels of IL-1 can indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a woman's health.

  2. TNF-alpha

    Time frame: Up to 2 years

    Serum inflammatory marker TNF-alpha. Higher levels of TNF-alpha can indicate more inflammation. TNF-alpha is examined to determine a person's inflammatory state.

  3. IL-6

    Time frame: Up to 2 years

    Serum IL-6 levels. IL-6 is examined to determine a person's inflammatory state. Higher levels of IL-6 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.

  4. IL-8

    Time frame: Up to 2 years

    IL-8 serum levels. IL-8 is examined to determine a person's inflammatory state. Higher levelf of IL-8 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.

  5. Flow-mediated dilation

    Time frame: Up to 2 years

    Flow-mediated dilation measures the diameter of vascular and endothelial cell function and predicts cardiovascular event risk. The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow.

  6. Serum Marker for Ovarian Aging

    Time frame: Up to 2 years

    Anti-mullerian hormones (AMH) serum levels will be analyzed. AMH is an indicator of ovarian aging and reflects egg supply. Lower levels of AMH indicate a lower egg supply.

  7. MENQOL survey

    Time frame: Up to 2 years

    Menopause-specific Quality of Life (MENQOL) measures quality of life in menopausal women. It is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual. There will be a overall score and we are examining if there is a change in response to treatment.

  8. Eaotoxin levels

    Time frame: Up to 2 years

    Eaotoxin is a inflammatory marker that increases when there is an inflammed state in a woman. Serum Eaotoxin will be measured before, during and at the end of the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Carrie Hsu, BA

CONTACT

[email protected]

303-724-5276

Nalia Naushad

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 16, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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