A comparison of an enteric coated and micro-coated formulation of ERr 731®

Current clinical and commercialization experiences have been with enteric-coated formulations of ERr 731®. With the demonstrated safety of this formulation and the absence of anthraquinones in the extract, there is interest in launching a micro-coated, but not enteric-coated, formulation to broaden the commercial availability of ERr 731® in new markets. It is proposed that a double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability.

Inclusion Criteria:

• Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive
• Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.

Exclusion Criteria:

• A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
• History of Breast or Uterine cancers.
• Known infection with HIV, Tuberculosis or Hepatitis B or C.
• Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)
• Hormonal Contraceptives: All formulations of synthetic estrogens and progestins
• Botanical Formulations - including phytoestrogens and progesterone-mimetic botanicals (Rhapontic Rhubarb, Soy Phytoestrogens, Hops (8-prenyl naringin) Red Clover, Kudzu, Chaste Tree Berry, Licorice, Resveratrol, Black Cohosh, Dong Quai, etc.)
• Use of Narcotics during the last 30 days
• Use of Anticoagulants during last 30 days
• Use of Corticosteroids during the last 30 days
• Use of controlled substances (other than marijuana or CBD) on a recreational basis during the last 30 days.
• Consumption of more than 3 alcoholic beverages per day (One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor)
• Pregnancy
• Breast Feeding

Double-blinded as to order formulations are received in a standard cross-over design with washout phase