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Completed

NCT Number: NCT00654082

A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Erectile Dysfunction Genital Diseases Genital Diseases, Male Impotence Injuries, Spinal Cord Male Urogenital Diseases Mental Disorders Nervous System Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Trauma Trauma, Nervous System Urogenital Diseases Wounds and Injuries

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Bahçelievler, Istanbul, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion criteria

-N/A

Treatment and study plan

Sildenafil

Drug

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

Placebo

Drug

placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks

Primary outcomes

  1. The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections

    Time frame: Weeks 6 and 14

Secondary outcomes

  1. Responses to the International Index of Erectile Function (IIEF)

    Time frame: Weeks 0, 6, 8, and 14

  2. Responses to the Global Efficacy Assessment (GEA) Question

    Time frame: Weeks 0, 6, 8, and 14

  3. Responses to questions on the Quality of Life (QoL) Questionnaire

    Time frame: Weeks 0, 6, 8, and 14

  4. Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions

    Time frame: Weeks 0, 6, 8, and 14

  5. Intercourse success rate derived from patient event log

    Time frame: Weeks 0, 6, 8, and 14

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2003
First posted
Apr 7, 2008
Registry last updated
Feb 1, 2021

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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