Menopausal symptoms
Conditions
Interventions
EstroG-100J
Placebo
Sponsors
Tsukuba International Clinical Pharmacology Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subjects with abilities to present consent who have been informed of the objectives and the contents of the present clinical trial, have sufficiently understood them, and have voluntarily expressed the consent by written documents. 2) Japanese adult females with pre-, peri- and post-menopausal symptoms. 3) Females with Kupperman's menopausal index (KMI) of not lower than 20.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of the mean change of Kupperman's menopausal index (KMI) (from week 0 to 8) between placebo and EstroG-100J groups | — |
Countries
Japan
Contacts
Public ContactMasaki Suzuki
Tsukuba International Clinical Pharmacology Clinic Volunteer Department
Outcome results
None listed