Clinical trial NCT00159900: Quality of Erection Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\]

Primary outcomes:
measure: Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).
Secondary outcomes:
measure: 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)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Rio Claro
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Rosenheim
country: Germany
facility: Pfizer Investigational Site
city: Starnberg
country: Germany
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Szczecin
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Bursa
country: Turkey
facility: Pfizer Investigational Site
city: Diyarbakir
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.