Clinical study on the efficacy and safety of EstroG-100J for menopausal symptoms: randomized double-blinded controlled study - Efficacy and safety of EstroG-100J

Tsukuba International Clinical Pharmacology Clinic0 个研究点目标入组 60 人开始时间: 2014年12月30日最近更新: 2023年10月17日

试验速览

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•1) Subjects with BMI of over 28. 2) Subjects who are treated for menopausal disorders (including those taking dietary supplements). 3) Subjects who either took foods or dietary supplements, or were treated with either oral or topical drugs containing estrogen or progesterone within 3 months before the informed consent. 4) Subjects with breast cancers, uterine cancers, ovary cancers or female-hormone-dependent cancers (including suspected cases), or those with histories of those diseases. 5) Subjects having first-degree family members with breast cancers or the histories of breast cancers. 6) Subjects with the histories of ovarian surgeries. 7) Subjects taking psychotropic drugs or drugs with psychological effects. 8) Subjects with psychological disorders or with the histories of those disorders. 9) Subjects with abnormal vaginal bleeding for more than one year after the menopause. 10) Subjects who have undergone hysterectomy. 11) Subjects with not-well-controlled hypertension. 12) Subjects with thyroid disorders. 13) Subjects with diabetes mellitus. 14) Subjects with coagulation disorders such as deep-vein thrombosis. 15) Subjects with abnormalities in either renal or liver function tests. 16) Subjects with either drug addiction or alcoholism. 17) Subjects who are judged to be inappropriate for the trial by either primary or other investigators.

发起方

Tsukuba International Clinical Pharmacology Clinic