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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Pfizer Investigational Site
      • Bursa, Turkey
        • Pfizer Investigational Site
      • Konya, Turkey
        • Pfizer Investigational Site
    • Istanbul
      • Bahcelievler, Istanbul, Turkey, 34580
        • Pfizer Investigational Site
    • Izmir
      • Balcova, Izmir, Turkey
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion Criteria:

-N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 2
Drug: placebo
placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks
Active Comparator: Arm 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Weeks 6 and 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Responses to the International Index of Erectile Function (IIEF)
Time Frame: Weeks 0, 6, 8, and 14
Weeks 0, 6, 8, and 14
Responses to the Global Efficacy Assessment (GEA) Question
Time Frame: Weeks 0, 6, 8, and 14
Weeks 0, 6, 8, and 14
Responses to questions on the Quality of Life (QoL) Questionnaire
Time Frame: Weeks 0, 6, 8, and 14
Weeks 0, 6, 8, and 14
Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions
Time Frame: Weeks 0, 6, 8, and 14
Weeks 0, 6, 8, and 14
Intercourse success rate derived from patient event log
Time Frame: Weeks 0, 6, 8, and 14
Weeks 0, 6, 8, and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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