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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00654082 |
To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.
Condition | Intervention | Phase |
---|---|---|
Spinal Cord Injury Erectile Dysfunction Spinal Cord Trauma Injuries, Spinal Cord Impotence |
Drug: sildenafil Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled, Randomized, Two-Way Cross-Over, Double-Blind, Flexible Dose, Multicenter Study to Evaluate the Efficacy and Safety of Viagra in Male Patients With Traumatic Spinal Cord Injury and Erectile Dysfunction |
Enrollment: | 88 |
Study Start Date: | September 2002 |
Study Completion Date: | August 2003 |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator |
Drug: sildenafil
sildenafil 50 mg tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks; after 2 weeks on treatment, doses could be escalated to 100 mg or reduced to 25 mg
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Arm 2: Placebo Comparator |
Drug: placebo
placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Patients were men with spinal cord injury and erectile dysfunction
Exclusion Criteria:
-N/A
Turkey | |
Pfizer Investigational Site | |
ANKARA, Turkey | |
Pfizer Investigational Site | |
BURSA, Turkey | |
Pfizer Investigational Site | |
KONYA, Turkey | |
Turkey, ISTANBUL | |
Pfizer Investigational Site | |
BAHCELIEVLER, ISTANBUL, Turkey, 34580 | |
Turkey, IZMIR | |
Pfizer Investigational Site | |
BALCOVA, IZMIR, Turkey |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A1481103 |
Study First Received: | March 31, 2008 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00654082 |
Health Authority: | Turkey: Ethics Committee |
Sexual Dysfunctions, Psychological Spinal Cord Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Sildenafil Trauma, Nervous System |
Genital Diseases, Male Spinal Cord Injuries Sexual Dysfunction, Physiological Spinal Injuries Mental Disorders Back Injuries Erectile Dysfunction |
Vasodilator Agents Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Nervous System Diseases |
Enzyme Inhibitors Cardiovascular Agents Sexual and Gender Disorders Pharmacologic Actions |