A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Citric Acid; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Documented Clinical diagnosis of Erectile Dysfunction (ED) by International Index of Erectile Function (IIEF) Erectile Function (EF) Domain score less than or equal to 25.

• Subjects must be in a stable relationship

Exclusion Criteria:

• Subject with resting sitting hypotension (BP <90/50 mmHg) or hypertension (BP>170/110 mmHg) and orthostatic hypotension.

• Subjects receiving any PDE (Phosphodiesterase)-5 inhibitors within 4 weeks prior to the date of screening.

• Subjects with severe hepatic impairment, a known history of retinitis pigmentare.

• Subjects with significant cardiovascular disease in the last 3 months (per medical history.