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Completed

NCT Number: NCT00598585

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

Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)

Completed

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

About this study

Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients meeting the CDC definition of CFS.
  • All races, ethnicities, socio-economic status (SES), and gender
  • Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).
  • Age less than 50. Because of concern of sildenafil exacerbating coronary artery disease, we will only enroll patients younger than 50.
  • Able to provide informed consent.
  • Willingness to be off all medicines and supplements for 3 weeks prior to the study.
  • Patients with psychiatric disorders (see below) will be included, if they could be off their medications, and if their psychiatric diagnosis clearly occurred after their fatigue symptoms began.
  • Patients with concurrent fibromyalgia will be allowed to participate if the meet diagnostic criteria for CFS.

Exclusion criteria

  • Disabilities that would prevent them from participating in the study.
  • Current use of prescription medicines (starting at 3 weeks prior to the study) and supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin. This includes herbal supplements and vitamins.
  • Existing medical illnesses, such as heart disease, hypertension, cancer, rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure disorders, severe obesity (BMI > 32 kg/m2),
  • Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and previous or current diagnosis of alcohol or substance abuse within the past year. Patients with depression of such severity as to warrant treatment with anti-depressants will be excluded.
  • Current abuse of illicit drugs or heavy ethanol use.
  • Pregnant women will be excluded because of radioactivity exposure from the SPECT scans.
  • Abnormal EKG
  • Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR tests.

Treatment and study plan

Sildenafil (Viagra)

Drug

25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation.

Placebo

Drug

Placebo pills 3X/day for 6 weeks

Primary outcomes

  1. Change in Fatigue Impact Scale at 6 Weeks

    Time frame: 6 weeks

    change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated

Sponsors and collaborators

Lead sponsor

Charles Drew University of Medicine and Science

Other

Collaborators

  • Pfizer

Registry information

Official study title

Phase 4 Study of the Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With Chronic Fatigue Syndrome.

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2008
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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