Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04584918
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum total testosterone concentration compared to baseline', 'timeFrame': 'Day 0, Day 21 and Day 35'}], 'secondaryOutcomes': [{'measure': 'Change in Q 9 of the AMS Questionnaire', 'timeFrame': 'Day 0, Day 21 and Day 35'}, {'measure': 'Change in Q17 of the AMS Questionnaire', 'timeFrame': 'Day 0, Day 21 and Day 35'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Aging']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.', 'detailedDescription': 'This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nMale ≥ 55 years of age\n\nExclusion Criteria:\n\nSevere lower urinary tract symptoms.\n\nCurrent use of any herbal and/or nutritional supplements that can interfere with testosterone.\n\nA history of cancer except melanoma skin cancer.\n\nCurrently receiving treatment with cancer chemotherapy or antiandrogens.\n\nChronic use of systemic glucocorticoids (use within \\>14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening.\n\nHistory of frequent opioid use \\>1 time/week during any week within 30 days prior to screening.\n\nHave a history of known angina.\n\nHave a history of severe liver disease or clinical evidence of hepatic impairment at screening.\n\nUntreated severe obstructive sleep apnea.\n\nAllergies to any of the ingredients in Euryco-10® or BioPerine.\n\nAny condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results"}, 'identificationModule': {'nctId': 'NCT04584918', 'briefTitle': 'An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovus Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement on Total Testosterone, Sex Drive and Energy Level in Senior Men', 'orgStudyIdInfo': {'id': 'INNV-BHT1000-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Jo Anna Williams', 'role': 'CONTACT', 'email': 'jwilliams@sdsm.info', 'phone': '619-265-7695'}, {'name': 'Irwin Goldstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Diego Sexual Medicine', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}