Phase 2 / Phase 3: testing Metformin for Menopause
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?
Official registry: https://clinicaltrials.gov/study/NCT06975111 · University of Colorado, Denver · enrollment listed as 200
What this phase means
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Metformin, semaglutide, or Anti-hypertensives. The registry lists allocation as randomized. 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?
They plan to enroll about 200 people at 3 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Interventions: Metformin, semaglutide, Anti-hypertensives, Lipid Lowering Medication, Life style intervention, Fezolinetant, Hormonal therapy
Primary outcome (registry wording): Epigenetic aging measurements of "PhenoAge"
Who it is for (from inclusion criteria)
- Ages 45 Years to 55 Years
- Women only
- In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea
- 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
Who the registry excludes
- 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 body-mass index (BMI)\> 30 kg/m2
Public study contact (from the registry)
Carrie Hsu, BA
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- University of Colorado-School of Medicine — Aurora, Colorado (recruiting)
- University of North Carolina, School of Medicine — Chapel Hill, North Carolina (recruiting)
- Virginia Commonwealth University — Richmond, Virginia (recruiting)
FAQ about this NCT record
Is NCT06975111 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06975111?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06975111?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary