Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Erectile Dysfunction

Eligibility:

MALE

18+ years

Phase:

PHASE4

Brief 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 Internation...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2008

Estimated Enrollment :

117 Patients enrolled

Trial Details

Trial ID

NCT00468650

Start Date

June 1 2007

End Date

February 1 2008

Last Update

February 18 2021

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Pfizer Investigational Site

México, D.F., Mexico, 11520

2

Pfizer Investigational Site

México, D.F., Mexico, 11850

3

Pfizer Investigational Site

Naucalpan, Edo. de México, Mexico, 53100

4

Pfizer Investigational Site

Zapopan, Jalisco, Mexico, 45040