A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00468650
First received: May 1, 2007
Last updated: March 17, 2009
Last verified: March 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 June 18, 2013