Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 11:38 PM
Study NCT ID:
NCT05959057
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERr 731® Formulation Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded as to order formulations are received in a standard cross-over design with washout phase'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-07-15', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal Tolerability', 'timeFrame': '14 days', 'description': 'Frequency of symptoms of gastrointestinal nature collected on a custom questionnaire'}], 'secondaryOutcomes': [{'measure': 'General Tolerability', 'timeFrame': '14 Days', 'description': 'Frequency of general symptoms collected on a custom questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Botanical supplement', 'Formulation', 'Rhapontic Rhubarb'], 'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'A comparison of an enteric coated and micro-coated formulation of ERr 731®', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 35-64, inclusive, preference given to Subjects Ages 45-54, inclusive\n* Preference given to symptomatic Subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias.\n\nExclusion Criteria:\n\n* A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.\n* History of Breast or Uterine cancers.\n* Known infection with HIV, Tuberculosis or Hepatitis B or C.\n* Hormone Replacement Therapy: All formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone)\n* Hormonal Contraceptives: All formulations of synthetic estrogens and progestins\n* 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.)\n* Use of Narcotics during the last 30 days\n* Use of Anticoagulants during last 30 days\n* Use of Corticosteroids during the last 30 days\n* Use of controlled substances (other than marijuana or CBD) on a recreational basis during the last 30 days.\n* 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)\n* Pregnancy\n* Breast Feeding'}, 'identificationModule': {'nctId': 'NCT05959057', 'acronym': 'EFE1', 'briefTitle': 'ERr 731® Formulation Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Metagenics, Inc.'}, 'officialTitle': 'ERr 731® Formulation Evaluation: A Comparison of Enteric Coated and Micro-coated ERr 731® Formulations', 'orgStudyIdInfo': {'id': '2023-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enteric/Micro Order', 'description': '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', 'interventionNames': ['Dietary Supplement: ERr 731 - Micro-coated', 'Dietary Supplement: ERr 731 - Enteric coated']}, {'type': 'EXPERIMENTAL', 'label': 'Micro/Enteric Order', 'description': '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', 'interventionNames': ['Dietary Supplement: ERr 731 - Micro-coated', 'Dietary Supplement: ERr 731 - Enteric coated']}], 'interventions': [{'name': 'ERr 731 - Micro-coated', 'type': 'DIETARY_SUPPLEMENT', 'description': 'natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.', 'armGroupLabels': ['Enteric/Micro Order', 'Micro/Enteric Order']}, {'name': 'ERr 731 - Enteric coated', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Estrovera'], 'description': 'natural extract of the Rheum Rhaponticum L plant (Siberian rhubarb). The primary active constituents of ERr 731® are hydroxystilbenes, primarily rhaponticin and desoxyrhaponticin.', 'armGroupLabels': ['Enteric/Micro Order', 'Micro/Enteric Order']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98332', 'city': 'Gig Harbor', 'state': 'Washington', 'country': 'United States', 'facility': 'Personalized Lifestyle Medicine Center', 'geoPoint': {'lat': 47.32926, 'lon': -122.58013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metagenics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}