CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 117 enrolled
Drug / intervention
sildenafil citratedrug
Likely dose
sildenafil citrate 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00468650
NCT00468650Phase 4Completed
CompareCT.gov

A Multicenter, Open Label, High Dose (100mg) Rapid Titration Study, To Evaluate The Efficacy And Satisfaction Of Patrex® (Sildenafil Citrate) In Men With Erectile Dysfunction In Mexico.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted May 3, 2007·Updated Feb 18, 2021

In Brief

A Phase 4 clinical trial evaluating sildenafil citrate for Erectile Dysfunction. Completed, enrolled 117 participants across 9 sites.

Detailed Summary

A multicenter open label study to assess the efficacy of sildenafil rapid dose titration to 100 mg in men with erectile dysfunction, based on the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2007
Enrollment StartJun 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 19.2 years ago

Interventions

sildenafil citratedrug

Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.