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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil / Placebo | Active Comparator | 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8. |
|
| Tadalafil / Placebo | Active Comparator | 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8. |
|
| Placebo / Sildenafil | Active Comparator | Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8. |
|
| Placebo / Tadalafil | Active Comparator | Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | 50 mg/day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo | 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. | after 4 weeks of placebo |
| Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug | 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. | after 4 weeks of active drug |
| Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo | 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. | after 4 weeks of placebo |
| Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo | 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 | Description | Time Frame |
|---|---|---|
| Hemoglobin Level at Week 0 | Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL. | week 0 |
| Hemoglobin Level Measured at Week 4 | Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Sheffield-Moore, PhD | University of Texas Medical Branch, Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555-0361 | United States |
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.
Participants were recruited from the community via flyers and local postings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil, Then Placebo | Sildenafil daily (50mg/day) for weeks 0-4. Then Placebo daily for weeks 5-8. |
| FG001 | Tadalfil, Then Placebo | Tadalafil (10mg/day) for week 0-4. Then Placebo daily for week 5-8. |
| FG002 | Placebo, Then Sildenafil | Placebo daily for weeks 0-4. Then Sildenafil daily (50mg/day) for weeks 5-8. |
| FG003 | Placebo, Then Tadalafil | Placebo for week 0-4, then Tadalafil (10mg/day) for week 5-8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Week 0-4 |
|
| ||||||||||||||||||
| Phase 2: Week 5-8. |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil, Then Placebo | Sildenafil (50mg/day) daily for weeks 0-4, then Placebo daily weeks 5-8. |
| BG001 | Tadalfil, Then Placebo | Tadalafil (10mg/day) daily for weeks 0-4, then Placebo daily for weeks 5-8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo | 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. | Posted | Mean | Standard Deviation | Newton-Meters | after 4 weeks of placebo |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil | Sildenafil (50mg/day) daily for 4 weeks. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness at site of muscle biopsy | Skin and subcutaneous tissue disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Sheffield-Moore | University of Texas Medical Branch | 409-772-8707 | melmoore@utmb.edu |
Not provided
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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Subjects were assigned to one of 4 arms:
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| tadalafil | Drug | 10 mg/day for 4 weeks. |
|
|
| Placebo | Drug | Placebo 1 capsule per day for four weeks. |
|
| after 4 weeks of active drug |
| after 4 weeks of placebo |
| Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug. | 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. | after 4 weeks of active drug |
| Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo. | 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. | after 4 weeks of placebo |
| Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug | 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. | after 4 weeks of active drug |
| Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0. | Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | week 0 |
| Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4. | Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | week 4 |
| Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8. | Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | week 8 |
| Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0. | Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | week 0 |
| Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4. | Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | week 4 |
| Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8. | Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | week 8 |
| Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo | 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. | after 4 weeks of placebo |
| Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug | 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. | after 4 weeks of active drug |
| Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0 | 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. | Week 0 |
| Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4 | 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. | week 4 |
| Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8 | 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. | week 8 |
| week 4 |
| Hemoglobin Level Measured at Week 8 | Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL. | week 8 |
| Hematocrit Level Measured at Week 0 | Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%. | week 0 |
| Hematocrit Level Was Measured at 4 Weeks | Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%. | 4 weeks |
| Hematocrit Level Measured at Week 8 | Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%. | week 8 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Placebo, Then Sildenafil | Placebo daily for weeks 0-4, then Sildenafil (50mg/day) daily for weeks 5-8. |
| BG003 | Placebo, Then Tadalafil | Placebo daily for weeks 0-4, then Tadalafil (10mg/day) daily for weeks 5-8. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Tadalafil, Then Placebo | 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8. tadalafil: 10 mg/day for 4 weeks. Placebo: Placebo 1 capsule per day for four weeks. |
| OG002 | Placebo, Then Sildenafil | Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8. Sildenafil: 50 mg/day for 4 weeks Placebo: Placebo 1 capsule per day for four weeks. |
| OG003 | Placebo, Then Tadalafil | Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8. tadalafil: 10 mg/day for 4 weeks. Placebo: Placebo 1 capsule per day for four weeks. |
|
|
| Primary | Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug | 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. | Posted | Mean | Standard Deviation | Newton-Meters | after 4 weeks of active drug |
|
|
|
| Primary | Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo | 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. | Posted | Mean | Standard Deviation | units on a scale | after 4 weeks of placebo |
|
|
|
| Primary | Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug | 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. | Posted | Mean | Standard Deviation | units on a scale | after 4 weeks of active drug |
|
|
|
| Secondary | Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo | 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. | Posted | Mean | Standard Deviation | Newton-Meters | after 4 weeks of placebo |
|
|
|
| Secondary | Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug. | 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. | Posted | Mean | Standard Deviation | Newton-Meters | after 4 weeks of active drug |
|
|
|
| Secondary | Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo. | 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. | Posted | Mean | Standard Deviation | Newton-Meters | after 4 weeks of placebo |
|
|
|
| Secondary | Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug | 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. | Posted | Mean | Standard Deviation | Newton-Meters | after 4 weeks of active drug |
|
|
|
| Secondary | Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0. | Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | Posted | Mean | Standard Deviation | kilograms | week 0 |
|
|
|
| Secondary | Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4. | Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | Posted | Mean | Standard Deviation | kilograms | week 4 |
|
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| Secondary | Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8. | Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | Posted | Mean | Standard Deviation | kilograms | week 8 |
|
|
|
| Secondary | Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0. | Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | Posted | Mean | Standard Deviation | kilograms | week 0 |
|
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| Secondary | Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4. | Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | Posted | Mean | Standard Deviation | kilograms | week 4 |
|
|
|
| Secondary | Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8. | Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry. | Posted | Mean | Standard Deviation | kilograms | week 8 |
|
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| Secondary | Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo | 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. | 1 subject did not complete the walking test | Posted | Mean | Standard Deviation | meters | after 4 weeks of placebo |
|
|
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| Secondary | Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug | 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. | 1 subject did not complete the walking test. | Posted | Mean | Standard Deviation | meter | after 4 weeks of active drug |
|
|
|
| Secondary | Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0 | 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. | Posted | Mean | Standard Deviation | scores on a scale | Week 0 |
|
|
|
| Secondary | Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4 | 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. | 1 subject did not complete the week 4 MFSI questionnaire | Posted | Mean | Standard Deviation | scores on a scale | week 4 |
|
|
|
| Secondary | Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8 | 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. | Posted | Mean | Standard Deviation | scores on a scale | week 8 |
|
|
|
| Other Pre-specified | Hemoglobin Level at Week 0 | Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL. | Posted | Mean | Standard Deviation | g/dL | week 0 |
|
|
|
| Other Pre-specified | Hemoglobin Level Measured at Week 4 | Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL. | Posted | Mean | Standard Deviation | g/dL | week 4 |
|
|
|
| Other Pre-specified | Hemoglobin Level Measured at Week 8 | Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL. | Posted | Mean | Standard Deviation | g/dL | week 8 |
|
|
|
| Other Pre-specified | Hematocrit Level Measured at Week 0 | Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%. | Posted | Mean | Standard Deviation | percent of red blood cells | week 0 |
|
|
|
| Other Pre-specified | Hematocrit Level Was Measured at 4 Weeks | Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%. | Posted | Mean | Standard Deviation | percent of red blood cells | 4 weeks |
|
|
|
| Other Pre-specified | Hematocrit Level Measured at Week 8 | Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%. | Posted | Mean | Standard Deviation | percent of red blood cells | week 8 |
|
|
|
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Tadalfil | Tadalafil (10mg/day) daily for 4 weeks. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Placebo | Placebo daily for week 4 weeks. | 0 | 18 | 0 | 18 | 0 | 18 |
| Syncope | General disorders | Syncope following administration of Sildenafil 50mg. |
|
Not provided
Not provided
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |