Status:
NOT_YET_RECRUITING
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Lead Sponsor:
University of Colorado, Denver
Conditions:
Menopause
Menopause Hot Flashes
Eligibility:
FEMALE
45-55 years
Phase:
PHASE2
PHASE3
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? Cou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06975111
Start Date
October 1 2025
End Date
October 1 2030
Last Update
May 16 2025
Active Locations (1)
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1
University of Colorado-School of Medicine
Aurora, Colorado, United States, 80045