Quality of Erection Study

Erectile Dysfunction Clinical Trial

Official title:

A Multicenter, Parallel Group Flexible Dose Study With A Double Blind, Randomized, Placebo Controlled Phase And An Open-Label Phase To Evaluate The Quality Of Erections In Men With Erectile Dysfunction Treated With Sildenafil Citrate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159900
• Other study ID #: A1481222
• Status: Completed
• Phase: Phase 4
• Start date: May 2005
• Est. completion date: January 2006

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male subjects aged 18-55
• Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion Criteria:

• Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening]

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Sildenafil Citrate

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Belo Horizonte	MG
Brazil	Pfizer Investigational Site	Rio Claro	SP
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Marburg
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Rosenheim
Germany	Pfizer Investigational Site	Starnberg
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Roma
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Szczecin
Poland	Pfizer Investigational Site	Warszawa
Turkey	Pfizer Investigational Site	Bursa
Turkey	Pfizer Investigational Site	Diyarbakir
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Izmir

Sponsors (1)

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

Countries where clinical trial is conducted

Brazil,  Germany,  Italy,  Poland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).
Secondary	Responses to the Quality of Erectile Questionnaire (QEQ) Responses to International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction)