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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
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 tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks
Pfizer Investigational Site
Bahçelievler, Istanbul, Turkey (Türkiye)
Pfizer Investigational Site
Balçova, İzmir, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, Turkey (Türkiye)
Pfizer Investigational Site
Bursa, Turkey (Türkiye)
Pfizer Investigational Site
Konya, Turkey (Türkiye)
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
Responses to the International Index of Erectile Function (IIEF)
Time frame: Weeks 0, 6, 8, and 14
Responses to the Global Efficacy Assessment (GEA) Question
Time frame: Weeks 0, 6, 8, and 14
Responses to questions on the Quality of Life (QoL) Questionnaire
Time frame: Weeks 0, 6, 8, and 14
Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions
Time frame: Weeks 0, 6, 8, and 14
Intercourse success rate derived from patient event log
Time frame: Weeks 0, 6, 8, and 14
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