Improving midlife women's health during the menopausal transition
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
This study will test whether medicines (metformin, semaglutide, blood pressure and cholesterol drugs) combined with lifestyle changes can reduce bothersome menopausal symptoms and lower future heart and metabolic disease risk in women aged 45–55 who are in the late menopausal transition.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 45 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06975111 on ClinicalTrials.gov |
What this trial studies
Women aged 45–55 in the late menopausal transition will be offered a package of evidence-based interventions including metformin, semaglutide, antihypertensives, lipid-lowering medications, and a structured lifestyle program. The trial will track menopausal symptoms, markers of inflammation, cardiometabolic risk factors, and measures of epigenetic aging over the treatment period. Some visits and data collection will be done via telehealth, so participants need smartphone and broadband access. Standard medical exclusions (for example pregnancy, untreated alcoholism, undiagnosed abnormal uterine bleeding, or specific thyroid cancer/MEN2 risks in higher-BMI participants) apply.
Who should consider this trial
Good fit: Ideal candidates are women aged 45–55 in the late menopausal transition (60–364 days without a period), not using hormone therapy or hormonal contraception, who have a uterus and at least one ovary and who have smartphone and broadband access.
Not a fit: People who are pregnant or trying to conceive, lack broadband access, have untreated alcoholism, undiagnosed abnormal uterine bleeding, or carry a personal/family history of medullary thyroid cancer or MEN2 (for participants with BMI > 30 kg/m2) may not be eligible or likely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce menopausal symptoms, lower inflammation and cardiometabolic risk, and slow biological aging to improve midlife health and long-term outcomes.
How similar studies have performed: Individual components such as metformin and semaglutide have demonstrated metabolic and weight benefits in other trials, but applying this combined drug-plus-lifestyle approach specifically during the menopausal transition is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado
- University of Colorado-School of Medicine — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Nanette Santoro, MD — University of Colorado, Denver
- Study coordinator: Carrie Hsu, BA
- Email: carrie.hsu@cuanschutz.edu
- Phone: 303-724-5276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.