Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
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| ClinicalTrials.gov Identifier: NCT00598585 |
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Recruitment Status :
Completed
First Posted : January 22, 2008
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
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Sponsor:
Charles Drew University of Medicine and Science
Collaborator:
Pfizer
Information provided by (Responsible Party):
Theodore Friedman, Charles Drew University of Medicine and Science
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Chronic Fatigue Syndrome |
| Interventions |
Drug: Sildenafil (Viagra) Drug: Placebo |
| Enrollment | 12 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Sildenafil | Placebo |
|---|---|---|
Arm/Group Description |
25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. | Placebo: Placebo |
| Period Title: Overall Study | ||
| Started | 6 | 6 |
| Completed | 5 | 6 |
| Not Completed | 1 | 0 |
| Reason Not Completed | ||
| Lost to Follow-up | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Sildenafil | Placebo | Total | |
|---|---|---|---|---|
Arm/Group Description |
Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. | Placebo: Placebo tid for 6 weeks | Total of all reporting groups | |
| Overall Number of Baseline Participants | 6 | 6 | 12 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| 39 (6) | 38 (9) | 38 (5) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| Female |
5 83.3%
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4 66.7%
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9 75.0%
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| Male |
1 16.7%
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2 33.3%
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3 25.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| Hispanic or Latino |
1 16.7%
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2 33.3%
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3 25.0%
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| Not Hispanic or Latino |
5 83.3%
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4 66.7%
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9 75.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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0 0.0%
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0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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| White |
6 100.0%
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6 100.0%
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12 100.0%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
small number of subjects enrolled in trial
More Information
Results Point of Contact
| Name/Title: | Theodore C. Friedman MD PhD |
| Organization: | Charles R. Drew University |
| Phone: | 3106685197 |
| EMail: | theodorefriedman@cdrewu.edu |
| Responsible Party: | Theodore Friedman, Charles Drew University of Medicine and Science |
| ClinicalTrials.gov Identifier: | NCT00598585 |
| Other Study ID Numbers: |
02-04-378-07 |
| First Submitted: | August 31, 2005 |
| First Posted: | January 22, 2008 |
| Results First Submitted: | April 14, 2017 |
| Results First Posted: | June 27, 2017 |
| Last Update Posted: | June 27, 2017 |



