Randomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal Symptoms

Inclusion criteria

• Healthy Females aged 40 to 65 years,
• Self-reporting menopausal symptoms (> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
• Reporting a variable cycle length of > 7 days different from normal
• BMI 20-40 kg/m2
• Able to read, understand, and complete the study questionnaire and records.
• Able to understand the study procedures.
• Able to comply with all study requirements.
• Written informed consent to participate in the study.
• Willingness to actively participate in the study and to come to the scheduled visits.

Exclusion criteria

• Pregnancy or breastfeeding.
• Immune insufficiency
• Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
• History of hysterectomy
• Women on hormone replacement therapy
• Use of systemic corticosteroids or immunosuppressant drugs.
• Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• Employees of the institute
• Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
• Alcohol or drug abuse,
• Use of hormonal contraceptives within the last 3 months
• BP ≥160/110 mmHg
• Oophorectomy or amenorrhea > two years