Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection
Estrogen therapy
Enfermedades Urogenitales+19
+ Enfermedades Genitales
+ Enfermedades Oclusivas Arteriales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1999
Fecha en la que se inscribió al primer participante.The incidence of atherosclerotic cardiovascular disease in women does not approach rates seen in men until approximately a decade following menopause, suggesting that estrogen is vasculoprotective. Infectious pathogens such a Chlamydia pneumoniae (C. pneumoniae) and human cytomegalovirus (hCMV) have been implicated in the pathogenesis of atherosclerosis. Experimental studies in cultured lymphocytes and animals suggest that estrogen stimulates cell-mediated immune responsiveness, observations that are potentially relevant to the eradication of intracellular pathogens including C. pneumoniae and hCMV. The purpose of this study is to determine whether estrogen therapy augments cell-mediated immune responsiveness in estrogen-deficient postmenopausal women who have serologic evidence of chronic infection with C. pneumoniae and/or hCMV. A comparison will be made between seropositive and seronegative women. We propose that estrogen therapy will stimulate a more efficient cell-mediated response to these chronically persistent infectious intracellular pathogens, resulting in eradication of these organisms that are of potential importance in atherogenesis.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 80 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Must be a postmenopausal woman 65 years of age or younger. Time since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml. Women must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG. Must not have used hormone replacement therapy within past 6 months. Must not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed. Must not have a history of alcoholism or binge-drinking. Must not have diabetes mellitus or known abnormal glucose intolerance test. Must not have a history of stroke, angina or myocardial infarction. Must not have a history of deep venous thrombosis/pulmonary embolism. Must not have a history of cancer (except for treated squamous cell and basal cell carcinomas). Must not have evidence of liver disease (liver function enzymes greater than twice the upper limit of normal). Must not have impaired renal function (creatinine greater than 1.6 mg/dl). Must not have a diagnosis of an autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, Raynaud's Disease). Must not have a history of intermittent vaginal bleeding. Must not have serum triglycerides greater than 400 mg/dL.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, United StatesAbrir National Heart, Lung and Blood Institute (NHLBI) en Google Maps