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

RecruitingPhase 2/3Healthy volunteers welcome

Who can join

Ages 45 to 55 · Women · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* aged 45-55
* In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea
* No current use of systemic hormone therapy or hormonal contraception, other than progestin-releasing IUDs or oral, micronized progesterone. Vaginal (non-systemic) estrogen use (FDA-approved products only, used as labelled) is permitted and is NOT an exclusion. Other forms of non-FDA approved hormones will need to be reviewed by the study physicians on-site to determine eligibility. Women choosing to discontinue hormonal contraception and/or systemic hormone therapy may become eligible for the study after a washout period
* 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
* No more than 5% weight loss in the last 3 months

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
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\> 30 kg/m2.

About the study

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.

What is being tested

Sponsor: University of Colorado, Denver · Participants: 200 · Started: Mar 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT06975111

Locations in the U.S.

ColoradoUniversity of Colorado-School of Medicine, Aurora
North CarolinaUniversity of North Carolina, School of Medicine, Chapel Hill
VirginiaVirginia Commonwealth University, Richmond

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.