Clinical trial NCT00245258: Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
Official title: A Multicenter, Double-Blind Placebo Controlled, Fixed Dose Study With An Open-Label, Flexible Dose Phase To Assess The Efficacy Of Sildenafil Citrate In Providing A Better Sexual Experience Including Quality Of Erections And Satisfaction In Men With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-27
Enrollment: 312
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to:

1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end of the double-blind phase
2. To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX_Q).


Eligibility criteria: Inclusion Criteria:

* Male subjects aged 18-65.
* 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: The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.
Secondary outcomes:
measure: The change from baseline to visit 6 (wk 12) in the IIEF-EF domain; the change from baseline to visit 4 (wk 8) and visit 6 (wk 12) in the domains and total score as well as the individual questions of the sexual experience questionnaire
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Karlshamn
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cappelleri JC, Tseng LJ, Stecher V, Goldstein I. Enriching the Interpretation of the Erectile Dysfunction Inventory of Treatment Satisfaction: Characterizing Success in Treatment Satisfaction. J Sex Med. 2018 May;15(5):732-740. doi: 10.1016/j.jsxm.2018.03.078.
citation: Kirby M, Creanga DL, Stecher VJ. Erectile function, erection hardness and tolerability in men treated with sildenafil 100 mg vs. 50 mg for erectile dysfunction. Int J Clin Pract. 2013 Oct;67(10):1034-9. doi: 10.1111/ijcp.12229.
citation: Claes HIM, Goldstein I, Althof SE, Berner MM, Cappelleri JC, Bushmakin AG, Symonds T, Schnetzler G. Understanding the effects of sildenafil treatment on erection maintenance and erection hardness. J Sex Med. 2010 Jun;7(6):2184-2191. doi: 10.1111/j.1743-6109.2010.01791.x. Epub 2010 Apr 1.
citation: Loran OB, Stroberg P, Lee SW, Park NC, Kim SW, Tseng LJ, Collins S, Stecher VJ. Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. J Sex Med. 2009 Oct;6(10):2826-35. doi: 10.1111/j.1743-6109.2009.01428.x.