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Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Theodore Friedman, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00598585
First received: August 31, 2005
Last updated: May 25, 2017
Last verified: April 2017
Results First Received: April 14, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sildenafil 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: Placebo

Participant Flow:   Overall Study
    Sildenafil   Placebo
STARTED   6   6 
COMPLETED   5   6 
NOT COMPLETED   1   0 
Lost to Follow-up                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sildenafil 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: Placebo tid for 6 weeks
Total Total of all reporting groups

Baseline Measures
   Sildenafil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 39  (6)   38  (9)   38  (5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  83.3%      4  66.7%      9  75.0% 
Male      1  16.7%      2  33.3%      3  25.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1  16.7%      2  33.3%      3  25.0% 
Not Hispanic or Latino      5  83.3%      4  66.7%      9  75.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      6 100.0%      6 100.0%      12 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Change in Fatigue Impact Scale at 6 Weeks   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small number of subjects enrolled in trial


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Theodore C. Friedman MD PhD
Organization: Charles R. Drew University
phone: 3106685197
e-mail: theodorefriedman@cdrewu.edu



Responsible Party: Theodore Friedman, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00598585     History of Changes
Other Study ID Numbers: 02-04-378-07
Study First Received: August 31, 2005
Results First Received: April 14, 2017
Last Updated: May 25, 2017