Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT04984993
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Andy.Graham@futuramedical.com', 'phone': '+44 1483 685682', 'title': 'Andrew Graham, Senior Clinical Project Manager', 'organization': 'Futura Medical Development Ltd.'}, 'certainAgreement': {'otherDetails': 'After completion, the results of the clinical investigation (CI) may be published (first publication shall be referred to as the "Primary Paper"). Results of the CI shall not be published before the primary paper after which PIs may propose publications, including or based on results of the CI, to the Sponsor for review at least 2 months before the planned submission for publication or public disclosure. The Sponsor will provide written approval or reasoned refusal for submission or disclosure.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '29 Weeks', 'description': 'Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.', 'eventGroups': [{'id': 'EG000', 'title': 'MED3000', 'description': 'MED3000 gel formulation topically applied to the glans penis\n\nMED3000: Gel formulation', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 94, 'otherNumAffected': 10, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tadalafil', 'description': 'Tadalafil (5 mg) tablets to be taken orally\n\nTadalafil 5mg: Tablets', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 94, 'otherNumAffected': 16, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea (Male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Non-cardiac chest pain (Male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Back Pain (Male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Headache (Male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Headache (Female)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal distension (Male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Gamma-glutamyltransferase increased (Male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pain in extremity (Male)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MED3000', 'description': 'MED3000 gel formulation topically applied to the glans penis\n\nMED3000: Gel formulation'}], 'classes': [{'categories': [{'measurements': [{'value': '5.73', 'spread': '1.00', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Significance level of 0.025', 'groupDescription': 'Null hypothesis: mu \\<= 0 versus alternative hypothesis: mu \\>0, where mu is the population mean change from baseline in the EF domain of the IIEF questionnaire at week 24.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Co-primary objectives:\n\n* Demonstrate an improvement compared to baseline of erectile function, in patients randomised to receive MED3000, using the IIEF-EF patient reported outcome instrument.\n* Observe a mean change from baseline of the IIEF-EF, in patients randomised to MED3000, greater or equal to the minimal clinically importance difference of 4.\n\nThe IIEF is a validated questionnaire, consisting of 15 questions, for detecting treatment changes in EF. The EF domain of IIEF is derived using questions 1, 2, 3, 4, 5 and 15. A score of 0 to 5 is awarded to each of questions 1 to 5 and a score of 1 to 5 is awarded to question 15. Higher scores indicate better sexual function. Domain score is computed by summing the scores for individual questions. The minimum and maximum possible scores are 1 and 30 respectively. Patients with a score of 21 or less are considered to have ED. Change from baseline = Week 24 score - Baseline score.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MED3000 randomised patients (the only group considered for this outcome). Week 24 values for patients who do not have a Week 24 IIEF-EF value due to early treatment discontinuation adversely related to randomised treatment were imputed as baseline value resulting in zero change from baseline. Week 24 values for patients with early termination discontinuation not adversely related to randomised treatment were imputed via multiple imputation method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MED3000', 'description': 'MED3000 gel formulation topically applied to the glans penis\n\nMED3000: Gel formulation'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '62.59', 'spread': '39.18', 'groupId': 'OG000'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '47.81', 'spread': '36.26', 'groupId': 'OG000'}]}]}, {'title': '5 minutes', 'categories': [{'measurements': [{'value': '24.01', 'spread': '33.43', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Significance level of 0.025', 'groupDescription': 'Null hypothesis: mu \\<= 30 versus alternative hypothesis: mu \\>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 15 minutes.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Significance level of 0.025', 'groupDescription': 'Null hypothesis: mu \\<= 30 versus alternative hypothesis: mu \\>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 10 minutes.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.890', 'groupIds': ['OG000'], 'pValueComment': 'Significance level of 0.025', 'groupDescription': 'Null hypothesis: mu \\<= 30 versus alternative hypothesis: mu \\>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 5 minutes.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting.\n\nPercentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 1 indicated a time of 5 (10, 15) minutes or less.\n\nQuestion 1 of the Onset of Action questionnaire:\n\n\\- After application of the gel/taking medication, when did you begin to notice your erection starting?', 'unitOfMeasure': 'percentage of uses per patient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MED3000 randomised patients (the only group considered for this outcome)'}, {'type': 'SECONDARY', 'title': 'Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MED3000', 'description': 'MED3000 gel formulation topically applied to the glans penis\n\nMED3000: Gel formulation'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '55.70', 'spread': '36.13', 'groupId': 'OG000'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '31.91', 'spread': '29.30', 'groupId': 'OG000'}]}]}, {'title': '5 minutes', 'categories': [{'measurements': [{'value': '13.72', 'spread': '22.33', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Significance level of 0.025', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3327', 'groupIds': ['OG000'], 'pValueComment': 'Significance level of 0.025', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG000'], 'pValueComment': 'Significance level of 0.025', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Demonstrate a speed of onset of action from application of MED3000 gel to the time when the patients is able to have penetrative sex.\n\nPercentage of MED3000 uses per patient that resulted in the patient being able to have penetrative sex within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 2 indicated a time of 5 (10, 15) minutes or less.\n\nQuestion 2 of the Onset of Action questionnaire:\n\n\\- After application of the gel/taking medication, when were you able to have penetrative sex?', 'unitOfMeasure': 'percentage of uses per patient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MED3000 randomised patients (the only group considered for this outcome)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MED3000', 'description': 'MED3000 gel formulation topically applied to the glans penis\n\nMED3000: Gel formulation'}, {'id': 'FG001', 'title': 'Tadalafil', 'description': 'Tadalafil (5 mg) tablets to be taken orally\n\nTadalafil 5mg: Tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Both patients moved to another country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The first informed consent was on September 14, 2021 and the last study visit was on June 13, 2022.', 'preAssignmentDetails': 'Of 232 screened patients (males and females enrolled for eligibility assessment), 192 patients and their partners were randomised to treatment. Of the 40 patients and partners that failed screening, 36 did not satisfy inclusion criteria and 2 were excluded for other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MED3000', 'description': 'MED3000 gel formulation topically applied to the glans penis\n\nMED3000: Gel formulation'}, {'id': 'BG001', 'title': 'Tadalafil', 'description': 'Tadalafil (5 mg) tablets to be taken orally\n\nTadalafil 5mg: Tablets'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46.1', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '41.5', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '12.7', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.3', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are presented separately for male participants and female partners.'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '68'}, {'value': '39.0', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '68'}, {'value': '40.5', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '68'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '69'}, {'value': '38.0', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '65'}, {'value': '39.0', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data are presented separately for male participants and female partners.'}, {'title': 'Age, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': '22-29', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '30-39', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '40-49', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '50-59', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '60-70', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '<22', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': '22-29', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '30-39', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '40-49', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '50-59', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '60-70', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '<22', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are presented separately for male participants and female partners.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity for male \\& female participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'Georgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are presented for both male and female participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '179.20', 'spread': '7.24', 'groupId': 'BG000'}, {'value': '179.43', 'spread': '7.66', 'groupId': 'BG001'}, {'value': '179.31', 'spread': '7.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are presented for male participants only as not measured in the females'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '177.50', 'groupId': 'BG000', 'lowerLimit': '167.0', 'upperLimit': '196.0'}, {'value': '180.00', 'groupId': 'BG001', 'lowerLimit': '156.0', 'upperLimit': '194.0'}, {'value': '179.00', 'groupId': 'BG002', 'lowerLimit': '156.0', 'upperLimit': '196.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data are presented for male participants only as not collected in females'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '88.84', 'spread': '15.36', 'groupId': 'BG000'}, {'value': '88.19', 'spread': '13.72', 'groupId': 'BG001'}, {'value': '88.52', 'spread': '14.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are presented for male participants only and not measured in females'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85.70', 'groupId': 'BG000', 'lowerLimit': '61.0', 'upperLimit': '129.0'}, {'value': '85.15', 'groupId': 'BG001', 'lowerLimit': '66.2', 'upperLimit': '130.0'}, {'value': '85.35', 'groupId': 'BG002', 'lowerLimit': '61.0', 'upperLimit': '130.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data are presented for male participants only as not collected for females'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.643', 'spread': '4.348', 'groupId': 'BG000'}, {'value': '27.459', 'spread': '4.372', 'groupId': 'BG001'}, {'value': '27.551', 'spread': '4.338', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are presented for male participants only as not determined in females'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.985', 'groupId': 'BG000', 'lowerLimit': '18.62', 'upperLimit': '39.64'}, {'value': '26.759', 'groupId': 'BG001', 'lowerLimit': '19.30', 'upperLimit': '43.12'}, {'value': '26.959', 'groupId': 'BG002', 'lowerLimit': '18.62', 'upperLimit': '43.12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data are presented for male participants only as not determined in females'}, {'title': 'Baseline Erectile Dysfunction (ED) severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Mild', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mild ED = IIEF-EF domain score of 17-25, Moderate ED = IIEF-EF domain score of 11-16, Severe ED = IIEF-EF domain score of \\<= 10.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are presented for male participants only as not relevant for females'}], 'populationDescription': 'Regional enrolment details are combined for both the male participants and their female partners.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-02', 'size': 1768713, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-21T03:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2021-07-26', 'resultsFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-18', 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Co-primary objectives:\n\n* Demonstrate an improvement compared to baseline of erectile function, in patients randomised to receive MED3000, using the IIEF-EF patient reported outcome instrument.\n* Observe a mean change from baseline of the IIEF-EF, in patients randomised to MED3000, greater or equal to the minimal clinically importance difference of 4.\n\nThe IIEF is a validated questionnaire, consisting of 15 questions, for detecting treatment changes in EF. The EF domain of IIEF is derived using questions 1, 2, 3, 4, 5 and 15. A score of 0 to 5 is awarded to each of questions 1 to 5 and a score of 1 to 5 is awarded to question 15. Higher scores indicate better sexual function. Domain score is computed by summing the scores for individual questions. The minimum and maximum possible scores are 1 and 30 respectively. Patients with a score of 21 or less are considered to have ED. Change from baseline = Week 24 score - Baseline score.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.', 'timeFrame': '24 weeks', 'description': 'Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting.\n\nPercentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 1 indicated a time of 5 (10, 15) minutes or less.\n\nQuestion 1 of the Onset of Action questionnaire:\n\n\\- After application of the gel/taking medication, when did you begin to notice your erection starting?'}, {'measure': 'Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.', 'timeFrame': '24 weeks', 'description': 'Demonstrate a speed of onset of action from application of MED3000 gel to the time when the patients is able to have penetrative sex.\n\nPercentage of MED3000 uses per patient that resulted in the patient being able to have penetrative sex within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 2 indicated a time of 5 (10, 15) minutes or less.\n\nQuestion 2 of the Onset of Action questionnaire:\n\n\\- After application of the gel/taking medication, when were you able to have penetrative sex?'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '22 Years', 'genderBased': True, 'genderDescription': 'Male patients who have had erectile dysfunction for at least 3 months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male heterosexual patients aged 22-70 years.\n* Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.\n* Involved in a continuous heterosexual relationship with their partner for at least 6 months.\n\nExclusion Criteria:\n\n* Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.\n* History of unstable medical or psychiatric condition or using any medication that, in the opinion of the Principal Investigator, is likely to affect the patient's ability to complete the investigation or precludes the patient's participation in the investigation."}, 'identificationModule': {'nctId': 'NCT04984993', 'briefTitle': 'Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Futura Medical Developments Ltd.'}, 'officialTitle': 'A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period', 'orgStudyIdInfo': {'id': 'FM71'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MED3000', 'description': 'MED3000 gel formulation topically applied to the glans penis', 'interventionNames': ['Device: MED3000 (Male)', 'Device: MED3000 (Female)']}, {'type': 'EXPERIMENTAL', 'label': 'Tadalafil', 'description': 'Tadalafil (5 mg) tablets to be taken orally', 'interventionNames': ['Drug: Tadalafil 5mg (Male)', 'Drug: Tadalafil 5mg (Female)']}], 'interventions': [{'name': 'MED3000 (Male)', 'type': 'DEVICE', 'description': 'Gel formulation', 'armGroupLabels': ['MED3000']}, {'name': 'Tadalafil 5mg (Male)', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Tadalafil']}, {'name': 'MED3000 (Female)', 'type': 'DEVICE', 'description': 'Gel formulation', 'armGroupLabels': ['MED3000']}, {'name': 'Tadalafil 5mg (Female)', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Tadalafil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '2600', 'city': 'Dupnitsa', 'country': 'Bulgaria', 'facility': 'Medical Center "Asklepii"OOD', 'geoPoint': {'lat': 42.26478, 'lon': 23.11723}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT Plovdiv AD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7500', 'city': 'Silistra', 'country': 'Bulgaria', 'facility': 'MHAT "Silistra"AD', 'geoPoint': {'lat': 44.1171, 'lon': 27.26056}}, {'zip': '1000', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Center "INTERMEDICA"ООD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Batumi', 'country': 'Georgia', 'facility': 'LTD Health', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'zip': '4600', 'city': 'Kutaisi', 'country': 'Georgia', 'facility': 'Jsc "Evex Clinics"', 'geoPoint': {'lat': 42.26791, 'lon': 42.69459}}, {'zip': '3700', 'city': 'Rustavi', 'country': 'Georgia', 'facility': 'Rustavi N2 Medical Diagnostic Center', 'geoPoint': {'lat': 41.56271, 'lon': 44.9787}}, {'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Clinic "GIDMEDI"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'JSC "Evex clinics"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0162', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Raymann LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '40-065', 'city': 'Katowice', 'country': 'Poland', 'facility': 'The Mikolowska Medical Center', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '40-611', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Provita Sp. z o.o.', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '30-074', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Medistica Osteomed', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-93', 'city': 'Lublin', 'country': 'Poland', 'facility': 'PROVITA Specialised Gynecology and Sexology Practice', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '05-077', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sexology and Pathology of Intercourse Clinic', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '53-532', 'city': 'Wroclaw', 'country': 'Poland', 'facility': "Ryszard Smoliński's Medical Cabinet", 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Arthur Burnett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Futura Medical Developments Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}