Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00654082
Other study ID # A1481103
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2002
Est. completion date August 2003

Study information

Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 19 Years and older
Eligibility Inclusion Criteria: -Patients were men with spinal cord injury and erectile dysfunction Exclusion Criteria: -N/A

Study Design


Intervention

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

Locations

Country Name City State
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Bahcelievler Istanbul
Turkey Pfizer Investigational Site Balcova Izmir
Turkey Pfizer Investigational Site Bursa
Turkey Pfizer Investigational Site Konya

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections Weeks 6 and 14
Secondary Responses to the International Index of Erectile Function (IIEF) Weeks 0, 6, 8, and 14
Secondary Responses to the Global Efficacy Assessment (GEA) Question Weeks 0, 6, 8, and 14
Secondary Responses to questions on the Quality of Life (QoL) Questionnaire Weeks 0, 6, 8, and 14
Secondary Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions Weeks 0, 6, 8, and 14
Secondary Intercourse success rate derived from patient event log Weeks 0, 6, 8, and 14
See also
  Status Clinical Trial Phase
Recruiting NCT02574572 - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury Phase 1
Recruiting NCT05941819 - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury N/A
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Recruiting NCT02331979 - Improving Bladder Function in SCI by Neuromodulation N/A
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Recruiting NCT02978638 - Electrical Stimulation for Continence After Spinal Cord Injury N/A
Completed NCT02262234 - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study Phase 1/Phase 2
Completed NCT02161913 - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers N/A
Withdrawn NCT02237547 - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury Phase 1/Phase 2
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Terminated NCT02080039 - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury N/A
Completed NCT01642901 - Zoledronic Acid in Acute Spinal Cord Injury Phase 3
Completed NCT01471613 - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury Phase 1/Phase 2
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Completed NCT02149511 - Longitudinal Morphometric Changes Following SCI
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT01025609 - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Completed NCT01086930 - Early Intensive Hand Rehabilitation After Spinal Cord Injury Phase 3
Terminated NCT01005615 - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury Phase 1/Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A