Clinical trial 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 to see if it can help with weight loss and high blood sugar levels in women going through menopause. It is designed to lower the amount of sugar your liver makes and help your body use insulin better.
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
- The study aims to find out if specific health interventions can reduce inflammation, improve heart health markers, and ease menopause symptoms.
- Who it's for
- The study is looking for midlife women who are going through or have recently gone through menopause.
- What's involved
- Participants will receive a package of evidence-based health interventions designed to support their well-being during the menopausal transition.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
- 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 amenorrhea
- No current use of systemic hormone therapy or hormonal contraception, other than progestin-releasing IUDs or oral, micronized progesterone.
- 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
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\> 30 kg/m2.
See the full eligibility 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.
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Aurora, Colorado, United States; Chapel Hill, North Carolina, United States; Richmond, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.