Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-19 @ 2:57 AM
Study NCT ID:
NCT03039504
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2017-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-30', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the International Index of Erectile Function (IIEF) score', 'timeFrame': 'Baseline - 30 days', 'description': 'Self reported erectile function; higher score indicates less dysfunction'}, {'measure': 'Change from baseline in the International Index of Erectile Function (IIEF) score', 'timeFrame': 'Baseline - 60 days', 'description': 'Self reported erectile function; higher score indicates less dysfunction'}, {'measure': 'Change from baseline in the International Index of Erectile Function (IIEF) score', 'timeFrame': 'Baseline - 90 days', 'description': 'Self reported erectile function; higher score indicates less dysfunction'}, {'measure': 'Change from baseline in the Aging Male Symptome Scale (AMS) score', 'timeFrame': 'Baseline - 30 days', 'description': 'Self reported symptoms; lower score indicates fewer/lesser symptoms'}, {'measure': 'Change from baseline in the Aging Male Symptome Scale (AMS) score', 'timeFrame': 'Baseline - 60 days', 'description': 'Self reported symptoms; lower score indicates fewer/lesser symptoms'}, {'measure': 'Change from baseline in the Aging Male Symptome Scale (AMS) score', 'timeFrame': 'Baseline - 90 days', 'description': 'Self reported symptoms; lower score indicates fewer/lesser symptoms'}, {'measure': 'Change from baseline in the Spielberger-Hanin anxiety test', 'timeFrame': 'Baseline - 30 days', 'description': 'Self-administered questionnaire; higher score indicates more anxiety'}, {'measure': 'Change from baseline in the Spielberger-Hanin anxiety test', 'timeFrame': 'Baseline - 60 days', 'description': 'Self-administered questionnaire; higher score indicates more anxiety'}, {'measure': 'Change from baseline in the Spielberger-Hanin anxiety test', 'timeFrame': 'Baseline - 90 days', 'description': 'Self-administered questionnaire; higher score indicates more anxiety'}, {'measure': 'Change from baseline in testosterone levels', 'timeFrame': 'Baseline - 30 days', 'description': 'Blood testosterone levels, pg/ml'}, {'measure': 'Change from baseline in testosterone levels', 'timeFrame': 'Baseline - 60 days', 'description': 'Blood testosterone levels, pg/ml'}, {'measure': 'Change from baseline in testosterone levels', 'timeFrame': 'Baseline - 90 days', 'description': 'Blood testosterone levels, pg/ml'}, {'measure': 'Change from baseline in follicle stimulating hormone (FSH) levels', 'timeFrame': 'Baseline - 30 days', 'description': 'Blood FSH levels, mIU/ml'}, {'measure': 'Change from baseline in follicle stimulating hormone (FSH) levels', 'timeFrame': 'Baseline - 60 days', 'description': 'Blood FSH levels, mIU/ml'}, {'measure': 'Change from baseline in follicle stimulating hormone (FSH) levels', 'timeFrame': 'Baseline - 90 days', 'description': 'Blood FSH levels, mIU/ml'}, {'measure': 'Change from baseline in luteinizing hormone (LH) levels', 'timeFrame': 'Baseline - 30 days', 'description': 'Blood LH levels, mIU/ml'}, {'measure': 'Change from baseline in luteinizing hormone (LH) levels', 'timeFrame': 'Baseline - 60 days', 'description': 'Blood LH levels, mIU/ml'}, {'measure': 'Change from baseline in luteinizing hormone (LH) levels', 'timeFrame': 'Baseline - 90 days', 'description': 'Blood LH levels, mIU/ml'}, {'measure': 'Change from baseline in Sex Hormone Binding Globulin (SHBG) levels', 'timeFrame': 'Baseline - 30 days', 'description': 'Blood SHBG levels, nmol/L'}, {'measure': 'Change from baseline in Sex Hormone Binding Globulin (SHBG) levels', 'timeFrame': 'Baseline - 60 days', 'description': 'Blood SHBG levels, nmol/L'}, {'measure': 'Change from baseline in Sex Hormone Binding Globulin (SHBG) levels', 'timeFrame': 'Baseline - 90 days', 'description': 'Blood SHBG levels, nmol/L'}, {'measure': 'Change from baseline in inhibin B levels', 'timeFrame': 'Baseline - 90 days', 'description': 'Blood inhibin B levels, ng/L'}, {'measure': 'Change from baseline in homocystein levels', 'timeFrame': 'Baseline - 90 days', 'description': 'Blood homocystein levels, umol/L'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Baseline - 90 days', 'description': 'Based on the results of Spielberger-Hanin anxiety test (score).'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline - 90 days', 'description': 'Based on the results of International Index of Erectile Function (IIEF) test (score)'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline - 90 days', 'description': 'Based on the results of Aging Male Symptoms (AMS) test (score)'}, {'measure': 'Positive dynamics of the primary endpoints', 'timeFrame': '30th, 60th, 90th days', 'description': 'Percent of patients corresponding to the primary endpoints with positive dynamics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Succinates', 'Dietary supplement'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blind, placebo-controlled, comparative, prospective study (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men with mild to moderate erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men, 18 years of age or older;\n* Patients diagnosed with "erectile dysfunctions" of various pathogenesis, typical form without complications;\n* Ability to read and understand informed consent in order to participate in the study;\n* Ability to follow study\'s conditions.\n\nExclusion Criteria:\n\n* Oncological illnesses, except those in complete remission for at least 5 years;\n* Conditions that may require emergency or planned hospitalization in the next 6 months;\n* Extragenital endocrine conditions (hormonally active) (thyroid, adrenal glands, pituitary, hypothalamus);\n* Surgeries on sex organ within 1 year of the screening;\n* Any surgeries within 3 months of the screening;\n* Psychiatric illnesses;\n* Diabetes mellitus;\n* Cryptorchidism\n* Taking other dietary supplements that can affect erectile dysfunction within 1 month of participating in the study;\n* High risk of non-compliance.'}, 'identificationModule': {'nctId': 'NCT03039504', 'briefTitle': 'Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Research Center, LLC'}, 'officialTitle': 'Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'Potensa02-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Potensa', 'description': 'succinate-based dietary supplement', 'interventionNames': ['Dietary Supplement: Potensa, a succinate-based dietary supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Potensa, a succinate-based dietary supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Potensa - a dietary supplement: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.', 'armGroupLabels': ['Potensa']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105425', 'city': 'Moscow', 'country': 'Russia', 'facility': 'N.A. Lopatkin Urology and Interventional Radiology Research Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Ryazan State Medical University named after academician I.P. Pavlov', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}], 'overallOfficials': [{'name': 'Evgenii A Efremov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'N.A. Lopatkin Urology and Interventional Radiology Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Center, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}