Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-29 @ 8:32 AM
Study NCT ID:
NCT01661595
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2012-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'melmoore@utmb.edu', 'phone': '409-772-8707', 'title': 'Melinda Sheffield-Moore', 'organization': 'University of Texas Medical Branch'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sildenafil', 'description': 'Sildenafil (50mg/day) daily for 4 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tadalfil', 'description': 'Tadalafil (10mg/day) daily for 4 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo daily for week 4 weeks.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Redness at site of muscle biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Syncope', 'notes': 'Syncope following administration of Sildenafil 50mg.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': '50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG001', 'title': 'Tadalafil, Then Placebo', 'description': '10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.69', 'spread': '33.71', 'groupId': 'OG000'}, {'value': '42.07', 'spread': '5.19', 'groupId': 'OG001'}, {'value': '67.17', 'spread': '26.87', 'groupId': 'OG002'}, {'value': '63.24', 'spread': '8.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Placebo', 'description': '50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG001', 'title': 'Tadalafil / Placebo', 'description': '10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG002', 'title': 'Placebo / Sildenafil', 'description': 'Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG003', 'title': 'Placebo / Tadalafil', 'description': 'Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.90', 'spread': '35.60', 'groupId': 'OG000'}, {'value': '42.48', 'spread': '6.30', 'groupId': 'OG001'}, {'value': '62.68', 'spread': '24.88', 'groupId': 'OG002'}, {'value': '63.25', 'spread': '15.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Placebo', 'description': '50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG001', 'title': 'Tadalafil / Placebo', 'description': '10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG002', 'title': 'Placebo / Sildenafil', 'description': 'Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG003', 'title': 'Placebo / Tadalafil', 'description': 'Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.33', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '1.83', 'groupId': 'OG002'}, {'value': '4.75', 'spread': '0.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of placebo', 'description': 'The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test after 4 weeks of placebo. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil / Placebo', 'description': '50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG001', 'title': 'Tadalafil / Placebo', 'description': '10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG002', 'title': 'Placebo / Sildenafil', 'description': 'Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8.\n\nSildenafil: 50 mg/day for 4 weeks\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}, {'id': 'OG003', 'title': 'Placebo / Tadalafil', 'description': 'Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.\n\ntadalafil: 10 mg/day for 4 weeks.\n\nPlacebo: Placebo 1 capsule per day for four weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '5.25', 'spread': '4.27', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '1.83', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of active drug', 'description': 'The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '145.86', 'spread': '97.73', 'groupId': 'OG000'}, {'value': '104.17', 'spread': '23.66', 'groupId': 'OG001'}, {'value': '149.14', 'spread': '62.67', 'groupId': 'OG002'}, {'value': '148.34', 'spread': '47.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '140.09', 'spread': '82.29', 'groupId': 'OG000'}, {'value': '110.39', 'spread': '21.26', 'groupId': 'OG001'}, {'value': '133.81', 'spread': '58.04', 'groupId': 'OG002'}, {'value': '139.96', 'spread': '50.47', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.15', 'spread': '49.46', 'groupId': 'OG000'}, {'value': '78.59', 'spread': '10.25', 'groupId': 'OG001'}, {'value': '117.71', 'spread': '39.86', 'groupId': 'OG002'}, {'value': '111.67', 'spread': '23.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '106.79', 'spread': '49.69', 'groupId': 'OG000'}, {'value': '79.33', 'spread': '11.69', 'groupId': 'OG001'}, {'value': '116.48', 'spread': '37.83', 'groupId': 'OG002'}, {'value': '114.75', 'spread': '36.49', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.60', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '41.43', 'spread': '4.72', 'groupId': 'OG001'}, {'value': '49.93', 'spread': '10.63', 'groupId': 'OG002'}, {'value': '54.45', 'spread': '14.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0', 'description': 'Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.29', 'spread': '14.40', 'groupId': 'OG000'}, {'value': '41.02', 'spread': '4.05', 'groupId': 'OG001'}, {'value': '50.61', 'spread': '10.67', 'groupId': 'OG002'}, {'value': '54.85', 'spread': '14.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4', 'description': 'Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.22', 'spread': '14.68', 'groupId': 'OG000'}, {'value': '40.76', 'spread': '4.38', 'groupId': 'OG001'}, {'value': '52.09', 'spread': '10.03', 'groupId': 'OG002'}, {'value': '55.10', 'spread': '14.42', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 8', 'description': 'Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.35', 'spread': '11.40', 'groupId': 'OG000'}, {'value': '37.21', 'spread': '6.81', 'groupId': 'OG001'}, {'value': '32.72', 'spread': '5.92', 'groupId': 'OG002'}, {'value': '32.10', 'spread': '6.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0', 'description': 'Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.16', 'spread': '12.42', 'groupId': 'OG000'}, {'value': '37.12', 'spread': '6.35', 'groupId': 'OG001'}, {'value': '32.30', 'spread': '5.55', 'groupId': 'OG002'}, {'value': '32.47', 'spread': '7.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4', 'description': 'Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.60', 'spread': '12.51', 'groupId': 'OG000'}, {'value': '37.02', 'spread': '6.21', 'groupId': 'OG001'}, {'value': '32.40', 'spread': '5.83', 'groupId': 'OG002'}, {'value': '32.79', 'spread': '7.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 8', 'description': 'Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '203.82', 'spread': '30.51', 'groupId': 'OG000'}, {'value': '189.79', 'spread': '38.12', 'groupId': 'OG001'}, {'value': '198.41', 'spread': '14.04', 'groupId': 'OG002'}, {'value': '202.80', 'spread': '37.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject did not complete the walking test'}, {'type': 'SECONDARY', 'title': 'Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '197.01', 'spread': '32.72', 'groupId': 'OG000'}, {'value': '178.56', 'spread': '17.84', 'groupId': 'OG001'}, {'value': '200.19', 'spread': '13.99', 'groupId': 'OG002'}, {'value': '203.46', 'spread': '31.11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.', 'unitOfMeasure': 'meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject did not complete the walking test.'}, {'type': 'SECONDARY', 'title': 'Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.66', 'spread': '19.55', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '5.45', 'groupId': 'OG001'}, {'value': '-8', 'spread': '3.61', 'groupId': 'OG002'}, {'value': '-3.75', 'spread': '9.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.33', 'spread': '26.08', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '10.97', 'groupId': 'OG001'}, {'value': '-6.33', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '12.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4', 'description': 'Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject did not complete the week 4 MFSI questionnaire'}, {'type': 'SECONDARY', 'title': 'Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.67', 'spread': '19.09', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '27.54', 'groupId': 'OG001'}, {'value': '-9.67', 'spread': '6.81', 'groupId': 'OG002'}, {'value': '-9.25', 'spread': '1.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 8', 'description': 'Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemoglobin Level at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.42', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '12.78', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '13.05', 'spread': '0.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0', 'description': 'Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemoglobin Level Measured at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.05', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '12.03', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '0.47', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4', 'description': 'Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemoglobin Level Measured at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.55', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '11.97', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '12.95', 'spread': '1.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 8', 'description': 'Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hematocrit Level Measured at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.53', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '38.55', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '37.25', 'spread': '2.07', 'groupId': 'OG002'}, {'value': '31.88', 'spread': '13.09', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0', 'description': 'Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.', 'unitOfMeasure': 'percent of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hematocrit Level Was Measured at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.08', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '37.38', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '38.13', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '39.1', 'spread': '1.81', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.', 'unitOfMeasure': 'percent of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hematocrit Level Measured at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'OG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'OG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'OG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.38', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '38.1', 'spread': '1.19', 'groupId': 'OG002'}, {'value': '38.4', 'spread': '3.24', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 8', 'description': 'Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.', 'unitOfMeasure': 'percent of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8.'}, {'id': 'FG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8.'}, {'id': 'FG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8.'}, {'id': 'FG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8.'}], 'periods': [{'title': 'Phase 1: Week 0-4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Phase 2: Week 5-8.', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the community via flyers and local postings.', 'preAssignmentDetails': '30 subjects enrolled in this study. 6 subjects failed the screening and were withdrawn. 6 subjects chose to withdraw participation before the study began. 18 subjects began the study. 2 subjects were withdrawn during the study. 16 subjects completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sildenafil, Then Placebo', 'description': 'Sildenafil (50mg/day) daily for weeks 0-4, then Placebo daily weeks 5-8.'}, {'id': 'BG001', 'title': 'Tadalfil, Then Placebo', 'description': 'Tadalafil (10mg/day) daily for weeks 0-4, then Placebo daily for weeks 5-8.'}, {'id': 'BG002', 'title': 'Placebo, Then Sildenafil', 'description': 'Placebo daily for weeks 0-4, then Sildenafil (50mg/day) daily for weeks 5-8.'}, {'id': 'BG003', 'title': 'Placebo, Then Tadalafil', 'description': 'Placebo daily for weeks 0-4, then Tadalafil (10mg/day) daily for weeks 5-8.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '4.16', 'groupId': 'BG000'}, {'value': '56', 'spread': '1.41', 'groupId': 'BG001'}, {'value': '52.4', 'spread': '1.51', 'groupId': 'BG002'}, {'value': '57.25', 'spread': '2.99', 'groupId': 'BG003'}, {'value': '54.6', 'spread': '3.22', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '30 subjects enrolled in this study. 6 subjects failed the screening and were withdrawn. 6 subjects chose to withdraw participation before the study began. 18 subjects began the study. 2 subjects were withdrawn during the study. 16 subjects completed the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects were assigned to one of 4 arms:\n\n1. Sildenafil (50mg/day) for weeks 0-4. Placebo for weeks 5-8.\n2. Tadalafil (10mg/day) for weeks 0-4. Placebo for weeks 5-8.\n3. Placebo for weeks 0-4. Sildenafil (50mg/day) for weeks 5-8.\n4. Placebo for weeks 0-4. Tadalafil (10mg/day) for weeks 5-8.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2012-08-07', 'resultsFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-19', 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemoglobin Level at Week 0', 'timeFrame': 'week 0', 'description': 'Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.'}, {'measure': 'Hemoglobin Level Measured at Week 4', 'timeFrame': 'week 4', 'description': 'Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.'}, {'measure': 'Hemoglobin Level Measured at Week 8', 'timeFrame': 'week 8', 'description': 'Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.'}, {'measure': 'Hematocrit Level Measured at Week 0', 'timeFrame': 'week 0', 'description': 'Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.'}, {'measure': 'Hematocrit Level Was Measured at 4 Weeks', 'timeFrame': '4 weeks', 'description': 'Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.'}, {'measure': 'Hematocrit Level Measured at Week 8', 'timeFrame': 'week 8', 'description': 'Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.'}], 'primaryOutcomes': [{'measure': 'Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.'}, {'measure': 'Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.'}, {'measure': 'Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo', 'timeFrame': 'after 4 weeks of placebo', 'description': 'The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test after 4 weeks of placebo. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.'}, {'measure': 'Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug', 'timeFrame': 'after 4 weeks of active drug', 'description': 'The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.'}], 'secondaryOutcomes': [{'measure': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.'}, {'measure': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug.', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.'}, {'measure': 'Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo.', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.'}, {'measure': 'Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.'}, {'measure': 'Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.', 'timeFrame': 'week 0', 'description': 'Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.'}, {'measure': 'Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.', 'timeFrame': 'week 4', 'description': 'Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.'}, {'measure': 'Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.', 'timeFrame': 'week 8', 'description': 'Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.'}, {'measure': 'Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.', 'timeFrame': 'week 0', 'description': 'Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.'}, {'measure': 'Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.', 'timeFrame': 'week 4', 'description': 'Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.'}, {'measure': 'Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.', 'timeFrame': 'week 8', 'description': 'Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.'}, {'measure': 'Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo', 'timeFrame': 'after 4 weeks of placebo', 'description': 'Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.'}, {'measure': 'Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug', 'timeFrame': 'after 4 weeks of active drug', 'description': 'Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.'}, {'measure': 'Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0', 'timeFrame': 'Week 0', 'description': 'Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.'}, {'measure': 'Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4', 'timeFrame': 'week 4', 'description': 'Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.'}, {'measure': 'Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8', 'timeFrame': 'week 8', 'description': 'Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fatigue', 'Fatigability', 'Surface Electromyography (sEMG)', 'cyclic guanosine monophosphate (cGMP)', 'Nitric Oxide (NO)', 'NO-cGMP', 'Phosphodiesterase (PDE)', 'Sildenafil', 'Tadalafil', 'Isotope', 'Infusion', 'Anabolism', 'Upregulation', 'Accelerometer', 'Placebo', 'Nitrosylation'], 'conditions': ['Fatigue']}, 'descriptionModule': {'briefSummary': 'This study is funded by the Moody Endowment. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle anabolism, muscle strength, physical function, and body composition in older individuals. Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and fatigability.', 'detailedDescription': 'The Investigators hypothesize that upregulation of skeletal muscle NO-cGMP mediated responses through phosphodiesterase (PDE) inhibition by sildenafil or tadalafil causes an acute anabolic response of skeletal muscle protein synthesis. NO is well-known to elicit vasodilation through stimulation of cGMP signaling, and NO-mediated changes in muscle perfusion may influence both skeletal muscle anabolism and perceptual fatigue. To measure skeletal muscle protein synthesis, we will infuse a stable isotope tracer of phenylalanine and measure its incorporation into skeletal muscle proteins following a dose of sildenafil, tadalafil, or placebo. The Investigators will also determine whether differences exist between men and women in response to PDE inhibition. As skeletal muscle NO-cGMP signaling has been implicated in fatigue responses, we will assess the acute effect of sildenafil and tadalafil on fatigue. Fatigue can be manifested both as a performance deficit at a local level (e.g., a reduced ability of skeletal muscle to produce power or force) as well as a subjective experience of lacking physical or mental energy. Accordingly, we will use more than one means (skeletal muscle performance, fatigue questionnaires, accelerometers) to study fatigue. The Investigators hypothesize that sildenafil or tadalafil will acutely reduce exercise-associated fatigability and skeletal muscle fatigue development'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 50-60 years of age\n2. Ability to sign consent form (score\\>23 on the 30-item Mini Mental Status examination, MMSE)\n3. Stable body weight for at least three months.\n\nExclusion Criteria:\n\n1. Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (\\>2/year) or significant weight loss in the past year).\n2. Pregnancy\n3. Significant heart, liver, kidney, blood or respiratory disease.\n4. Peripheral vascular disease.\n5. Diabetes mellitus or other untreated endocrine disease.\n6. Active cancer\n7. Use of nitrates.\n8. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.\n9. Alcohol or drug abuse.\n10. Severe depression (\\>5 on the 15-item Geriatric Depression Scale, GDS).\n11. Cardiac abnormalities such as cardiac shunt or previously diagnosed pulmonary hypertension.\n12. Systolic blood pressure \\<100 or\\>150, diastolic blood pressure \\<60 or 90\\>. This range is smaller than the acceptable range stated in the prescribing information for sildenafil/tadalafil (90/50 and \\<170/110).'}, 'identificationModule': {'nctId': 'NCT01661595', 'briefTitle': 'The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue.', 'orgStudyIdInfo': {'id': '12-153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sildenafil / Placebo', 'description': '50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8.', 'interventionNames': ['Drug: Sildenafil', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tadalafil / Placebo', 'description': '10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8.', 'interventionNames': ['Drug: tadalafil', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo / Sildenafil', 'description': 'Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8.', 'interventionNames': ['Drug: Sildenafil', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo / Tadalafil', 'description': 'Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8.', 'interventionNames': ['Drug: tadalafil', 'Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Viagra', 'Revatio'], 'description': '50 mg/day for 4 weeks', 'armGroupLabels': ['Placebo / Sildenafil', 'Sildenafil / Placebo']}, {'name': 'tadalafil', 'type': 'DRUG', 'otherNames': ['Cialis', 'Adcirca'], 'description': '10 mg/day for 4 weeks.', 'armGroupLabels': ['Placebo / Tadalafil', 'Tadalafil / Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 1 capsule per day for four weeks.', 'armGroupLabels': ['Placebo / Sildenafil', 'Placebo / Tadalafil', 'Sildenafil / Placebo', 'Tadalafil / Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555-0361', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Melinda Sheffield-Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Medical Branch, Galveston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}