ERr 731® Formulation Evaluation

Menopause Clinical Trial

— EFE1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05959057
• Other study ID #: 2023-002
• Status: Completed
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: August 18, 2023

Study information

• Verified date: October 2023
• Source: Metagenics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• ERr 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.
• ERr 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.

Locations

Country	Name	City	State
United States	Personalized Lifestyle Medicine Center	Gig Harbor	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Metagenics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Tolerability	Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire	14 days
Secondary	General Tolerability	Frequency of general symptoms collected on a custom questionnaire	14 Days