Clinical trial

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

Recruiting now · Phase 2, Phase 3 · 1 countries · Registry ID NCT06975111

Recruiting nowPhase 2, Phase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to 55 Years

SexFemale

Healthy volunteersAccepted

ConditionMenopause, Menopause Hot Flashes, Menopause Related Conditions, Cardiovascular

Full registry criteria

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.

Treatments and study arms

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.

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 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

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.