Improving midlife women's health during the menopausal transition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Women aged 45–55 in the late menopausal transition will be offered a package of evidence-based interventions including metformin, semaglutide, antihypertensives, lipid-lowering medications, and a structured lifestyle program. The trial will track menopausal symptoms, markers of inflammation, cardiometabolic risk factors, and measures of epigenetic aging over the treatment period. Some visits and data collection will be done via telehealth, so participants need smartphone and broadband access. Standard medical exclusions (for example pregnancy, untreated alcoholism, undiagnosed abnormal uterine bleeding, or specific thyroid cancer/MEN2 risks in higher-BMI participants) apply.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Colorado-School of Medicine
  Aurora, Colorado, United States Recruiting
• University of North Carolina, School of Medicine
  Chapel Hill, North Carolina, United States Recruiting
• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Nanette Santoro, MD — University of Colorado, Denver
• Study coordinator: Carrie Hsu, BA
• Email: carrie.hsu@cuanschutz.edu
• Phone: 303-724-5276

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dietary guidelines-based eating plan to reduce menopausal symptoms in overweight and obese women

  A randomized trial will test whether following healthy eating guidance from Brazil’s dietary guidelines can lessen menopausal symptoms in women who are overweight or obese.

  Recruiting Federal University of Health Science of Porto Alegre · Porto Alegre, Rio Grande do Sul · NCT07822230

• Haelan 951 for menopause symptoms in peri- and postmenopausal women

  This open-label study tests daily Haelan 951, a fermented soy product, to see if it helps with hot flashes, sleep, and quality of life in peri- and postmenopausal women.

  Recruiting Spectrum Clinical Research, LLC · Kansas City, Missouri · NCT07751029

• Virtual registry for menopause and perimenopause in Australia

  This study is creating an online registry to collect information from Australian women about their experiences with menopause and perimenopause to help improve healthcare and support for them.

  Recruiting Bespoke Clinical Research · Adelaide · NCT06487130

• Impact of Duavive on mood and anxiety in menopausal women

  This study is testing if a new hormone treatment can help improve mood and reduce anxiety in women going through menopause.

  Recruiting Phase 1 St. Joseph's Healthcare Hamilton · Hamilton, Ontario · NCT04478305

• Hop extract vs soy isoflavone for menopausal symptoms

  This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.

  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• Resveratrol and Estrogen Receptors in Postmenopausal Women with CAD

  This study tests whether taking resveratrol is safe and can change estrogen-related markers in postmenopausal women with coronary artery disease.

  Recruiting InCor Heart Institute · São Paulo, São Paulo · NCT07865377

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.