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O estudo clínico NCT06975111 para Menopausa, Menopause Hot Flashes, Condições relacionadas à menopausa, Cardiovascular está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

Ainda não recrutando
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O estudo clínico NCT06975111 vai avaliar o tratamento para Menopausa, Menopause Hot Flashes, Condições relacionadas à menopausa, Cardiovascular. Este é um ensaio intervencionista de Fase II Fase III. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de outubro de 2025, com o objetivo de incluir 200 participantes. Coordenado por a Universidade do Colorado em Denver e deve ser concluído em 1 de outubro de 2030. Essas informações foram atualizadas no ClinicalTrials.gov em 16 de maio de 2025.
Resumo
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

Condições
MenopausaMenopause Hot FlashesCondições relacionadas à menopausaCardiovascular
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
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Outros IDs do estudo
  • 25-0943
  • U1111-1322-1036 (Outro identificador) (World Health Organization)
Número NCT
NCT06975111
Data de início (real)
2025-10-01
Última atualização postada
2025-05-16
Data de conclusão (estimada)
2030-10-01
Inscrição (estimada)
200
Tipo de estudo
Intervencionista
FASE
Fase II
Fase III
Status
Ainda não recrutando
Propósito principal
Tratamento
Alocação do design
Não randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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 ativoAt 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 ativoOverweight 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 ativoWomen 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 ativoWomen 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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
45 Years
Sexos elegíveis
Feminino
Aceita voluntários saudáveis
Sim
  • 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 logoUniversidade do Colorado em Denver491 estudos clínicos ativos para explorar
Contato central do estudo
Contato: Katherine Kuhn, MS, 303-724-5276, [email protected]
Contato: Nalia Naushad, [email protected]
1 Locais do estudo em 1 países

Colorado

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