A study to compare the symptomatic response in Indian menopausal women with different Estrogen preparations for treatment of vasomotor symptoms/vaginal atrophy

Walter Bushnell Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Menopausal women upto 70 years of age
•2.Symptomatic women with natural menopause
•3.Hysterectomised women with one or both ovaries preserved, considered only if serum FSH >40 IU/L and serum estradiol < 20 IU/L
•4.Women with bilateral oophrectomy
•5.Women with menopause due to premature ovarian failure
•6.Amenorrhoea for more than 1 year
•7.Currently experiencing vasomotor symptoms i.e hot flushes, night sweats, insomnia, sleep disturbances
•8.Currently experiencing dyspareunia, urinary symptoms such as frequency, urgency, dysuria, burning micturition, incontinence etc.

•1.Tobacco or alcohol abuser.
•2.History of malignant diseases.
•3.Abnormal mammogram within two years of study entry
•4.History of hormone dependent tumors
•5.Women with chronic diseases, such as uncontrolled hypertension; diabetes; liver, kidney and thyroid dysfunction
•6.Women on Long-term therapy such as Antiepileptic drugs or Diuretics
•7.Prior intake of hormonal medications within the 3 months
•8.Women with history of thrombophlebitis, estrogen-related thrombosis or thromboembolism, Cerebrovascular accident, with known or suspected estrogen-dependent tumor, undiagnosed vaginal bleeding, Migraine, Uterine disorders, Breast disorders, Gallbladder disease, Areterial thrombosis and Hypercholesterolemia
•9.Obese women: BMI36
•10.Known hypersensitivity to drugs used in the study

发起方

Walter Bushnell Pvt Ltd