Clinical trial NCT05959057: ERr 731® Formulation Evaluation
Official title: ERr 731® Formulation Evaluation: A Comparison of Enteric Coated and Micro-coated ERr 731® Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Botanical supplement
Formulation
Rhapontic Rhubarb
Lead sponsor: Metagenics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 15
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal Tolerability
timeFrame: 14 days
Secondary outcomes:
measure: General Tolerability
timeFrame: 14 Days
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: Personalized Lifestyle Medicine Center
state: Washington
Study officials:
References: