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Recruiting NCT06975111

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

Phase II / Phase III Interventional Menopause Menopause Hot Flashes Menopause Related Conditions Cardiovascular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin, semaglutide, Anti-hypertensives, Lipid Lowering Medication.
Who it may be relevant to
Registry conditions: Menopause, Menopause Hot Flashes, Menopause Related Conditions, Cardiovascular. Basic parameters: 45 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Metformin
    Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
  • Drug semaglutide
    Overweight women and women with obesity will take Semaglutide for weight-loss
  • Drug Anti-hypertensives
    a. Antihypertensives, with the goal of maintaining blood pressure at 130/80 or lower per ACC guidelines19. Per current clinical guidelines and standard of care, hypertension will be treated first with monotherapy using either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic provided that are no contraindications.
  • Drug Lipid Lowering Medication
    . First line agents will be generic statin medications (atorvastatin or rosuvastatin)whichever is covered by the participant's health insurance), barring contraindication to their use.
  • Behavioral Life style intervention
    will simply be followed and given preventive advice (maintenance of a normal BMI and physical activity, moderation in salt intake, and no more than 1 alcoholic drink per day). They will be provided with a wearable activity monitor. This advice will be based on guidelines by the American Heart Association and the Menopause Society.
  • Drug Fezolinetant
    Women with menopausal symptoms will be treated with hormone therapy (estrogen and progesterone) if appropriate, or with a neurokinin receptor antagonist (Fezolinetant). This can be treatment for women in any arm of the study as well as an arm by its self.
  • Drug Hormonal therapy
    Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.

Primary outcome measures

  • Epigenetic aging measurements of "PhenoAge" [Time frame: Up to 2 years]
  • Epigenetic aging measurements of "GrimAge" [Time frame: Up to 2 years]
Secondary outcome measures (8)
  • IL-1 [Time frame: Up to 2 years]
  • TNF-alpha [Time frame: Up to 2 years]
  • IL-6 [Time frame: Up to 2 years]
  • IL-8 [Time frame: Up to 2 years]
  • Flow-mediated dilation [Time frame: Up to 2 years]
  • Serum Marker for Ovarian Aging [Time frame: Up to 2 years]
  • MENQOL survey [Time frame: Up to 2 years]
  • Eaotoxin levels [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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 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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Colorado-School of Medicine — Aurora
  • University of North Carolina, School of Medicine — Chapel Hill
  • Virginia Commonwealth University — Richmond

Publications

  • Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160. PMID 1285753
  • SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. PMID 26551272
  • Greendale GA, Huang MH, Wight RG, Seeman T, Luetters C, Avis NE, Johnston J, Karlamangla AS. Effects of the menopause transition and hormone use on cognitive performance in midlife women. Neurology. 2009 May 26;72(21):1850-7. doi: 10.1212/WNL.0b013e3181a71193. PMID 19470968
  • Matthews KA, Crawford SL, Chae CU, Everson-Rose SA, Sowers MF, Sternfeld B, Sutton-Tyrrell K. Are changes in cardiovascular disease risk factors in midlife women due to chronological aging or to the menopausal transition? J Am Coll Cardiol. 2009 Dec 15;54(25):2366-73. doi: 10.1016/j.jacc.2009.10.009. PMID 20082925
  • Samargandy S, Matthews KA, Brooks MM, Barinas-Mitchell E, Magnani JW, Janssen I, Kazlauskaite R, El Khoudary SR. Abdominal visceral adipose tissue over the menopause transition and carotid atherosclerosis: the SWAN heart study. Menopause. 2021 Mar 1;28(6):626-633. doi: 10.1097/GME.0000000000001755. PMID 33651741
  • Tanaka T, Basisty N, Fantoni G, Candia J, Moore AZ, Biancotto A, Schilling B, Bandinelli S, Ferrucci L. Plasma proteomic biomarker signature of age predicts health and life span. Elife. 2020 Nov 19;9:e61073. doi: 10.7554/eLife.61073. PMID 33210602
  • Thurston RC, Carroll JE, Levine M, Chang Y, Crandall C, Manson JE, Pal L, Hou L, Shadyab AH, Horvath S. Vasomotor Symptoms and Accelerated Epigenetic Aging in the Women's Health Initiative (WHI). J Clin Endocrinol Metab. 2020 Apr 1;105(4):1221-7. doi: 10.1210/clinem/dgaa081. PMID 32080740
  • Fahy GM, Brooke RT, Watson JP, Good Z, Vasanawala SS, Maecker H, Leipold MD, Lin DTS, Kobor MS, Horvath S. Reversal of epigenetic aging and immunosenescent trends in humans. Aging Cell. 2019 Dec;18(6):e13028. doi: 10.1111/acel.13028. Epub 2019 Sep 8. PMID 31496122

Identifiers

NCT: NCT06975111 · 25-0943 · U1111-1322-1036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗