Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms

Inclusion criteria

• Signed and dated informed consent
• Women in the age between 45 and 60 years considered late peri- (defined as having had a menstrual period more than 3 months ago but less than 12 months ago) or postmenopausal (defined as at least 12 consecutive months without any menstrual flow) at the time of screening
• Menopause symptoms, defined as a score of at least 5 in the Menopausal Rating Scale (MRS) at screening
• Body Mass Index between 18 and 40 kg/m2 at the time of screening

Exclusion criteria

• Allergy/hypersensitivity/intolerance to any components in the Kudzu herbal extract powder capsules
• Past or present significant co-morbidity including, but not limited to: Uncontrolled, severe renal, hepatic, cardiovascular, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease
• History of breast cancer or other malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
• Known history of clinically significant thromboembolism
• Current alcohol abuse
• Pregnancy, determined by positive serum human chorionic gonadotropin (hCG) test prior to randomization, except for women considered postmenopausal
• Breastfeeding women
• Participation in a study trial with any investigational new drug or food supplement within 3 months prior to the start of the study
• Clinically significant ECG abnormalities, as judged by the investigator
• Clinically significant biochemistry abnormalities including but not limited to ALT or AST >2.5 x ULN or other clinically significant liver function parameters, as judged by the investigator
• Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination
• Use of local or systemic conventional hormone therapy regardless of indication or alternative medication including dietary supplements for the treatment of menopausal symptoms within 28 days prior to randomization.