Menopause
Conditions
Keywords
Botanical supplement, Formulation, Rhapontic Rhubarb
Brief summary
A comparison of an enteric coated and micro-coated formulation of ERr 731®
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTERr 731 - Micro-coated
natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.
DIETARY_SUPPLEMENTERr 731 - Enteric coated
natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.
Sponsors
Metagenics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blinded as to order formulations are received in a standard cross-over design with washout phase
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerability | 14 days | Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Tolerability | 14 Days | Frequency of general symptoms collected on a custom questionnaire |
Countries
United States
Outcome results
None listed