Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT01008605
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2009-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Caverject User Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.83', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Lower limit, 95% one-sided CI', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '95.83', 'ciLowerLimit': '87.46', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\\>) 80% overall.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.'}], 'classes': [{'title': 'Very useful', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat useful', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Not very useful', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not useful at all', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Each participant tested one device/dose combination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.'}], 'classes': [{'title': 'Very clear', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat clear', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Not very clear', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not clear at all', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Each participant tested one device/dose combination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.'}], 'classes': [{'title': 'No steps particularly difficult', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Attaching needle', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Mixing solution', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Getting the air out of syringe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dialing dose', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pushing plunger', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Each participant tested one device/dose combination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.'}], 'classes': [{'title': 'Very easy', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat easy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Somewhat difficult', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Very difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Each participant tested one device/dose combination.'}, {'type': 'SECONDARY', 'title': 'Time Required to Perform Each Step While Using the Caverject Impulse Delivery System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Caverject 10 Mcg Device, 2.5 Mcg Dose Setting', 'description': 'Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG001', 'title': 'Caverject 10 Mcg Device, 5.0 Mcg Dose Setting', 'description': 'Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG002', 'title': 'Caverject 10 Mcg Device, 7.5 Mcg Dose Setting', 'description': 'Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG003', 'title': 'Caverject 10 Mcg Device, 10 Mcg Dose Setting', 'description': 'Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG004', 'title': 'Caverject 20 Mcg Device, 5.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG005', 'title': 'Caverject 20 Mcg Device, 10.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG006', 'title': 'Caverject 20 Mcg Device, 15.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG007', 'title': 'Caverject 20 Mcg Device, 20.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.'}], 'classes': [{'title': 'Step 1: Assembly (n=6, 6, 6, 7, 6, 5, 6, 6)', 'categories': [{'measurements': [{'value': '103.2', 'spread': '16.98', 'groupId': 'OG000'}, {'value': '141.7', 'spread': '26.17', 'groupId': 'OG001'}, {'value': '119.2', 'spread': '58.60', 'groupId': 'OG002'}, {'value': '115.4', 'spread': '33.53', 'groupId': 'OG003'}, {'value': '127.5', 'spread': '54.57', 'groupId': 'OG004'}, {'value': '110.2', 'spread': '31.40', 'groupId': 'OG005'}, {'value': '109.7', 'spread': '28.77', 'groupId': 'OG006'}, {'value': '107.2', 'spread': '52.70', 'groupId': 'OG007'}]}]}, {'title': 'Step 2: Mixing solution (n=6, 5, 6, 7, 5, 5, 6, 6)', 'categories': [{'measurements': [{'value': '55.5', 'spread': '28.28', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '30.94', 'groupId': 'OG001'}, {'value': '61.0', 'spread': '38.78', 'groupId': 'OG002'}, {'value': '58.0', 'spread': '37.1', 'groupId': 'OG003'}, {'value': '50.2', 'spread': '22.97', 'groupId': 'OG004'}, {'value': '43.8', 'spread': '38.21', 'groupId': 'OG005'}, {'value': '61.2', 'spread': '16.44', 'groupId': 'OG006'}, {'value': '51.8', 'spread': '35.31', 'groupId': 'OG007'}]}]}, {'title': 'Step 3: De-aerating (n=6, 5, 6, 7, 5, 5, 6, 6)', 'categories': [{'measurements': [{'value': '55.8', 'spread': '18.27', 'groupId': 'OG000'}, {'value': '50.8', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '62.3', 'spread': '41.55', 'groupId': 'OG002'}, {'value': '52.7', 'spread': '26.02', 'groupId': 'OG003'}, {'value': '48.8', 'spread': '43.00', 'groupId': 'OG004'}, {'value': '44.0', 'spread': '18.12', 'groupId': 'OG005'}, {'value': '48.2', 'spread': '18.18', 'groupId': 'OG006'}, {'value': '57.2', 'spread': '20.18', 'groupId': 'OG007'}]}]}, {'title': 'Step 4: Setting the dose (n=6, 4, 6, 7, 5, 5, 6, 6', 'categories': [{'measurements': [{'value': '21.0', 'spread': '9.65', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '7.09', 'groupId': 'OG001'}, {'value': '70.3', 'spread': '106.57', 'groupId': 'OG002'}, {'value': '47.3', 'spread': '37.80', 'groupId': 'OG003'}, {'value': '43.2', 'spread': '41.76', 'groupId': 'OG004'}, {'value': '26.2', 'spread': '14.60', 'groupId': 'OG005'}, {'value': '23.8', 'spread': '11.37', 'groupId': 'OG006'}, {'value': '37.3', 'spread': '22.34', 'groupId': 'OG007'}]}]}, {'title': 'Step 5: Injecting dose (n=6, 5, 6, 7, 5, 5, 6, 6)', 'categories': [{'measurements': [{'value': '98.7', 'spread': '85.41', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '21.21', 'groupId': 'OG001'}, {'value': '62.8', 'spread': '68.99', 'groupId': 'OG002'}, {'value': '80.0', 'spread': '85.65', 'groupId': 'OG003'}, {'value': '42.0', 'spread': '28.55', 'groupId': 'OG004'}, {'value': '51.6', 'spread': '42.69', 'groupId': 'OG005'}, {'value': '31.0', 'spread': '14.34', 'groupId': 'OG006'}, {'value': '41.5', 'spread': '18.22', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Each participant tested one device/dose combination. n = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Providing Comments to Any Question on the Participant Assessment Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Caverject 10 Mcg Device, 2.5 Mcg Dose Setting', 'description': 'Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG001', 'title': 'Caverject 10 Mcg Device, 5.0 Mcg Dose Setting', 'description': 'Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG002', 'title': 'Caverject 10 Mcg Device, 7.5 Mcg Dose Setting', 'description': 'Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG003', 'title': 'Caverject 10 Mcg Device, 10 Mcg Dose Setting', 'description': 'Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG004', 'title': 'Caverject 20 Mcg Device, 5.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG005', 'title': 'Caverject 20 Mcg Device, 10.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG006', 'title': 'Caverject 20 Mcg Device, 15.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.'}, {'id': 'OG007', 'title': 'Caverject 20 Mcg Device, 20.0 Mcg Dose Setting', 'description': 'Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.'}], 'classes': [{'title': 'Instructions provided were useful?', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Instructions provided were clear?', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Most difficult step?', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Syringe easy to use?', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Each participant tested one device/dose combination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \\[PGE1\\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '8.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 44 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Between 45 and 64 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-04', 'studyFirstSubmitDate': '2009-11-05', 'resultsFirstSubmitDate': '2012-02-28', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-28', 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System', 'timeFrame': 'Day 1', 'description': 'Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\\>) 80% overall.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.'}, {'measure': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.'}, {'measure': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.'}, {'measure': 'Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4', 'timeFrame': 'Day 1', 'description': 'Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult'}, {'measure': 'Time Required to Perform Each Step While Using the Caverject Impulse Delivery System', 'timeFrame': 'Day 1', 'description': 'Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.'}, {'measure': 'Number of Participants Providing Comments to Any Question on the Participant Assessment Tool', 'timeFrame': 'Day 1', 'description': 'Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6711035&StudyName=Caverject%20user%20study', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the usability of the system.', 'detailedDescription': 'demonstrate usability'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 40 to 70\n\nExclusion Criteria:\n\nPrior syringe skills'}, 'identificationModule': {'nctId': 'NCT01008605', 'briefTitle': 'Caverject User Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.', 'orgStudyIdInfo': {'id': 'A6711035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caverject Impulse', 'description': 'representative users', 'interventionNames': ['Other: delivery system']}], 'interventions': [{'name': 'delivery system', 'type': 'OTHER', 'description': 'syringe', 'armGroupLabels': ['Caverject Impulse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}