A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms

A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms

This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.

Inclusion Criteria:

• Age group between 45 and 65 at the time of informed consent.
• Physician diagnosis of menopause.
• History of substantial hot flashes > 4 episodes /day for last 2 weeks.
• Being post-menopausal with an intact uterus.
• Subject has provided signed and dated written informed consent before admission to the study.

Exclusion Criteria:

• Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.
• Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.
• Women involved in other clinical studies within the last 30 days.
• Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.