NCT05959057

ERr 731® Formulation Evaluation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Metagenics, Inc. · Industry
• Sex: Female
• Age: 35 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopause

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2023-05-24
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2023-07-25
• Last updated: 2023-10-30

Locations

1 site across 1 country: United States