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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00468650
First received: May 1, 2007
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: sildenafil citrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) [ Time Frame: Week 6 LOCF ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.


Secondary Outcome Measures:
  • International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6 [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline [ Time Frame: Week 2, Week 4, and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  • International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.

  • Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline [ Time Frame: Week 2, Week 4, and Week 6 ] [ Designated as safety issue: No ]
    QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

  • Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.

  • Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

  • Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.

  • Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline [ Time Frame: Week 2, Week 4, and Week 6 ] [ Designated as safety issue: No ]
    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

  • Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome

  • Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline [ Time Frame: Week 2, Week 4, and Week 6 ] [ Designated as safety issue: No ]
    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

  • Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 ["Were you able to insert your penis into your partner's vagina?"] = "Yes") / (number of occasions where SEP Question 2 was answered "Yes" or "No").

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 ["Were you satisfied with the hardness of your erection?"] = "Yes") / (number of occasions where SEP Question 4 was answered "Yes" or "No").

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 ["Were you satisfied with this sexual encounter?"] = "Yes") / (number of occasions where SEP Question 5 was answered "Yes" or "No")

  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline [ Time Frame: Week 2, Week 4, and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

  • 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 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of "Yes" responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)

  • Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

  • Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)

  • Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

  • Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)

  • Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

  • Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)

  • Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

  • Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)

  • 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 [ Time Frame: Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)

  • 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 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
    Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)


Enrollment: 117
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open label
Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive Patrex® 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to Patrex® 100 mg PRN for the following four weeks.
Drug: sildenafil citrate
Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468650

Locations
Mexico
Pfizer Investigational Site
Mexico, D.f., Mexico, 11520
Pfizer Investigational Site
Mexico, D.f., Mexico, 11850
Pfizer Investigational Site
Mexico, DF, Mexico, 11850
Pfizer Investigational Site
Mexico, Distrito Federal, Mexico, 11850
Pfizer Investigational Site
Naucalpan, Edo. de México, Mexico, 53100
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45040
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45200
Pfizer Investigational Site
Aguascalientes, Mexico, 20000
Pfizer Investigational Site
Durango, Mexico, 34300
Pfizer Investigational Site
Naucalpan Edo. de Mexico, Mexico
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00468650     History of Changes
Other Study ID Numbers: A1481251
Study First Received: May 1, 2007
Results First Received: February 12, 2009
Last Updated: April 21, 2015
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 30, 2015