NCT06975111 Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
| NCT ID | NCT06975111 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Colorado, Denver |
| Condition | Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2026-03-01 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Nanette Santoro, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06975111 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 55 Years, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06975111 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06975111 currently recruiting?
Yes, NCT06975111 is actively recruiting participants. Contact the research team at carrie.hsu@cuanschutz.edu for enrollment information.
Where is the NCT06975111 trial being conducted?
This trial is being conducted at Aurora, United States, Chapel Hill, United States, Richmond, United States.
Who is sponsoring the NCT06975111 clinical trial?
NCT06975111 is sponsored by University of Colorado, Denver. The principal investigator is Nanette Santoro, MD at University of Colorado, Denver. The trial plans to enroll 200 participants.