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:
Pfizer
ClinicalTrials.gov Identifier:
NCT00468650
First received: May 1, 2007
Last updated: March 17, 2009
Last verified: March 2009
  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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline [ Time Frame: Week 2, Week 4, and Week 6 ] [ Designated as safety issue: No ]
  • Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
  • 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): Erection Domain- Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
  • 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): Satisfaction Domain - Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
  • 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): Relationship Domain - Change From Week 2 [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]
  • 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 ]

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, 11850
Pfizer Investigational Site
Mexico, D.f., Mexico, 11520
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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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: March 17, 2009
Health Authority: Mexico: Ministry of Health

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

ClinicalTrials.gov processed this record on July 23, 2014