A multicenter, multinational, randomized, parallel group, placebo-controlled, double-blind study to evaluate efficacy and safety of a food supplement containing 80 mg soy isoflavones ZAVITAL in the control of climacteric syndrome in postmenopausal women - ND

ZAMBON GROUP0 个研究点目标入组 360 人开始时间: 2006年11月10日最近更新: 2012年3月19日

适应症

试验速览

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•61485;Post menopausal women aged between 40-65, with at least 6 months since the last menstrual period or 6 weeks from bilateral oophorectomy, and the serum levels of FSH 8805; 30 IU/L and estradiol 8804; 40 pg/ml at baseline. 61485;Patients with a minimum average of 5 moderate to severe hot flushes including night sweats in 24h during the last 7 days on patient s diary before randomization
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•61485;Concomitant therapies such as Hormone Replacement Therapy HRT and any other hormone therapies estrogens, progesterone, androgens in the last 3 months before the inclusion into the study; other agents for the treatment of hot flushes such as megestrol acetate, clonidine, vitamin E, phenobarbital, ergotamine tartrate, antidepressant agents and patients habitually taking 4 days a week products containing isoflavones in the last month before screening visit. 61485;Patients with severe hepatic failure AST and ALT twice the upper limit , renal failure creatinine 1.5 mg/dl , diabetes mellitus type I or uncontrolled type II , uncontrolled dysthyroidism, manifest heart failure condition NYHA II-IV , severe neurologic diseases, as well as patients with hypersensitivity to soy products. 61485;Patients with previous breast cancer in the last 5 years or suspected breast nodules at physical examination

发起方

ZAMBON GROUP