ERr 731® Formulation Evaluation

Study Overview
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Brief Summary
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A comparison of an enteric coated and micro-coated formulation of ERr 731®

Detailed Description
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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.

Official Title
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ERr 731® Formulation Evaluation: A Comparison of Enteric Coated and Micro-coated ERr 731® Formulations

Conditions
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Menopause

Intervention / Treatment
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* Dietary Supplement: ERr 731 - Micro-coated
* Dietary Supplement: ERr 731 - Enteric coated


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteric/Micro Order<br>Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 1 will receive enteric coated ERr 731® during treatment phase 1 and micro-coated ERr 731®during treatment phase 2 | Dietary Supplement: ERr 731 - Micro-coated<br>* natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.<br>Dietary Supplement: ERr 731 - Enteric coated<br>* natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.<br>* Other names: Estrovera;|
| Experimental: Micro/Enteric Order<br>Subjects will receive randomly two distinct formulations of ERr 731® in a 43 day trial consisting of treatment phase 1 (14-days), washout phase (14-days),treatment phase 2 (14-days): Arm 2 will receive micro-coated ERr 731® during treatment phase 1 and enteric coated ERr 731®during treatment phase 2 | Dietary Supplement: ERr 731 - Micro-coated<br>* natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.<br>Dietary Supplement: ERr 731 - Enteric coated<br>* natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.<br>* Other names: Estrovera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerability | Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Tolerability | Frequency of general symptoms collected on a custom questionnaire | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botanical supplement, Formulation, Rhapontic Rhubarb