ERr 731® Formulation Evaluation

Not Applicable

Completed

• Conditions: Menopause
• Interventions: Dietary Supplement: ERr 731 - Micro-coated; Dietary Supplement: ERr 731 - Enteric coated

• Registration Number: NCT05959057
• Lead Sponsor: Metagenics, Inc.

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study Start: 2023-05-24
• Study First Submitted QC: 2023-07-15
• Study First Posted: 2023-07-25
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enteric/Micro Order	ERr 731 - Micro-coated	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
Micro/Enteric Order	ERr 731 - Micro-coated	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
Micro/Enteric Order	ERr 731 - Enteric coated	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
Enteric/Micro Order	ERr 731 - Enteric coated	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

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerability	14 days	Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire

Secondary Outcome Measures

Name	Time	Method
General Tolerability	14 Days	Frequency of general symptoms collected on a custom questionnaire

Trial Locations

Locations (1)

Personalized Lifestyle Medicine Center; 🇺🇸 Gig Harbor, Washington, United States