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

What this trial studies

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 in scope

• Menopause
• Menopause Hot Flashes
• Menopause Related Conditions
• Cardiovascular

Interventions

• 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…
• 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.
• 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…
• 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…

Who can join

Women only · Ages 45 Years to 55 Years · Accepts healthy volunteers.

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE2, PHASE3
• Start date: 2026-03-01
• Primary completion: 2029-10-31
• Last update posted: 2026-04-30
• First posted: 2025-05-16

Sponsor & contact

Lead sponsor: University of Colorado, Denver (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Epigenetic aging measurements of "PhenoAge" (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.
• Epigenetic aging measurements of "GrimAge" (Up to 2 years)
  Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.