Clinical trial NCT00468650: A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.
Official title: A Multicenter, Open Label, High Dose (100mg) Rapid Titration Study, To Evaluate The Efficacy And Satisfaction Of Patrex® (Sildenafil Citrate) In Men With Erectile Dysfunction In Mexico.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 117
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 International Index of Erectile Function (IIEF) questionnaire.


Eligibility 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.

Primary outcomes:
measure: International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)
timeFrame: Week 6 LOCF
Secondary outcomes:
measure: International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6
timeFrame: Week 2, Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2
timeFrame: Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2
timeFrame: Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2
timeFrame: Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline
timeFrame: Week 2, Week 4, and Week 6
measure: International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2
timeFrame: Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline
timeFrame: Week 2, Week 4, and Week 6
measure: Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline
timeFrame: Week 2, Week 4, and Week 6
measure: Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2
timeFrame: Week 4 and Week 6
measure: Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline
timeFrame: Week 2, Week 4, and Week 6
measure: Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline
timeFrame: Week 2, Week 4, and Week 6
measure: Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
timeFrame: Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline
timeFrame: Week 2, Week 4 and Week 6
measure: Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2
timeFrame: Week 4 and Week 6
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: Distrito Federal
city: Naucalpan
country: Mexico
facility: Pfizer Investigational Site
state: Edo. De México
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Aguascalientes
country: Mexico
facility: Pfizer Investigational Site
city: Durango
country: Mexico
facility: Pfizer Investigational Site
city: Naucalpan Edo. De Mexico
country: Mexico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: