Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
University of Colorado, Denver
200 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria7
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
Overweight women and women with obesity will take Semaglutide for weight-loss
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.
. 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.
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.
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.
Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06975111