Recruiting PHASE2, PHASE3 Menopause

New treatment option for Menopause

Official title Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

ClinicalTrials.gov ID: NCT06975111

What this study is testing

What is Metformin?

Metformin is an investigational medicine, being studied as a potential treatment for menopause.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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?
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 45 to 55, women only. Healthy volunteers may be eligible.

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Aurora, Colorado, United States
  • Chapel Hill, North Carolina, United States
  • Richmond, Virginia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 45 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aurora, Colorado, United States; Chapel Hill, North Carolina, United States; Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.