Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorUniversity of Colorado, Denver
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metformin
- semaglutide
- Anti-hypertensives
- Lipid Lowering Medication
- Life style intervention
- Fezolinetant
- Hormonal therapy
Treatment groups
200 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov