A Phase 4 interventional study of sildenafil and placebo in Spinal Cord Injury, Erectile Dysfunction and Spinal Cord Trauma, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 5 sites in Turkey. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 88 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Patients were men with spinal cord injury and erectile dysfunction
Exclusion Criteria:
-N/A
Drug: sildenafil
Drug: placebo
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
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
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.