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El ensayo clínico NCT06975111 para Menopausia, Menopause Hot Flashes, Condiciones relacionadas con la menopausia, Cardiovascular está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

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El ensayo clínico NCT06975111 está diseñado para estudiar el tratamiento de Menopausia, Menopause Hot Flashes, Condiciones relacionadas con la menopausia, Cardiovascular. Este es un estudio intervencionista de Fase II Fase III. Su estado actual es: aún no recluta. Se planea que el reclutamiento se inicie el 1 de octubre de 2025 hasta que el ensayo reclute a 200 participantes. Dirigido por la Universidad de Colorado en Denver, se espera que finalice el 1 de octubre de 2030. Los datos se actualizaron por última vez en ClinicalTrials.gov el 16 de mayo de 2025.
Resumen
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.
Título oficial

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

Condiciones médicas
MenopausiaMenopause Hot FlashesCondiciones relacionadas con la menopausiaCardiovascular
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este ensayo clínico:
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Otros ID del ensayo
  • 25-0943
  • U1111-1322-1036 (Otro identificador) (World Health Organization)
Número del NCT
NCT06975111
Inicio del ensayo (real)
2025-10-01
Última actualización
2025-05-16
Fecha de finalización (estimada)
2030-10-01
Inscripción (prevista)
200
Tipo de estudio
Intervencionista
FASE
Fase II
Fase III
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalPreventative Health Advice
Participants will be given preventative health advice and asked to wear an activity \& sleep monitor.
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.
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.
Hormonal Therapy
Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.
Comparador activoAt Risk for Heart Disease
Medications will be given to each participant in this arm that lowers your heart disease risk.
Metformina
Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
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.
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.
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.
Comparador activoOverweight Women
Women who fit in this category will receive medication for lowering insulin resistance and/or a weight loss medication.
Metformina
Metformin will be given to participants who have a elevated HbA1c and also for weightloss.
Semaglutide
Overweight women and women with obesity will take Semaglutide for weight-loss
Comparador activoWomen with Obesity
Women that are over a BMI of 30 kg/m2 will be offered a GLP-1 antagonist.
Semaglutide
Overweight women and women with obesity will take Semaglutide for weight-loss
Comparador activoWomen With Hot Flashes
Women with Hot flashes will have either hormonal or non-hormonal medication to reduce the number and/or severity of hot flashes.
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.
Hormonal Therapy
Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Epigenetic aging measurements of "PhenoAge"
Change in epigenetic aging, as assessed by PhenoAge. PhenoAge calculates a biological age score based on key biomarkers circulating in the bloodstream. A lower PhenoAge score suggests slower biological aging, while a higher score indicates accelerated aging.
Up to 2 years
Epigenetic aging measurements of "GrimAge"
Epigenetic aging, as assessed by GrimAge. GrimAge assesses lifespan from examining DNA Methylation.
Up to 2 years
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
IL-1
Inflammatory IL-1 serum levels, examined to determine a person's inflammatory state. Higher levels of IL-1 can indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a woman's health.
Up to 2 years
TNF-alpha
Serum inflammatory marker TNF-alpha. Higher levels of TNF-alpha can indicate more inflammation. TNF-alpha is examined to determine a person's inflammatory state.
Up to 2 years
IL-6
Serum IL-6 levels. IL-6 is examined to determine a person's inflammatory state. Higher levels of IL-6 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.
Up to 2 years
IL-8
IL-8 serum levels. IL-8 is examined to determine a person's inflammatory state. Higher levelf of IL-8 indicate more inflammation. Being in an "inflamed state" can have detrimental effects on a women's health.
Up to 2 years
Flow-mediated dilation
Flow-mediated dilation measures the diameter of vascular and endothelial cell function and predicts cardiovascular event risk. The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow.
Up to 2 years
Serum Marker for Ovarian Aging
Anti-mullerian hormones (AMH) serum levels will be analyzed. AMH is an indicator of ovarian aging and reflects egg supply. Lower levels of AMH indicate a lower egg supply.
Up to 2 years
MENQOL survey
Menopause-specific Quality of Life (MENQOL) measures quality of life in menopausal women. It is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual. There will be a overall score and we are examining if there is a change in response to treatment.
Up to 2 years
Eaotoxin levels
Eaotoxin is a inflammatory marker that increases when there is an inflammed state in a woman. Serum Eaotoxin will be measured before, during and at the end of the study.
Up to 2 years
Criterios de elegibilidad

Criterios de edad
Adulto
Edad mínima
45 Years
Criterios de sexo
Mujer
Admisión de voluntarios sanos
Sí
  • 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

  • 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.
University of Colorado, Denver logoUniversidad de Colorado en Denver491 ensayos clínicos activos para explorar
Contactos centrales del ensayo
Contacto: Katherine Kuhn, MS, 303-724-5276, [email protected]
Contacto: Nalia Naushad, [email protected]
1 Sitios del ensayo en 1 países

Colorado

University of Colorado-School of Medicine, Aurora, Colorado, 80045, United States