Phase 4
N=117
A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00468650 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Mar 2009
Primary outcome: Primary: International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) — 10.96 score on scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sildenafil citrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) |
10.96 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6 |
7.14; 10.57; 10.93; 10.95 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2 |
3.48; 3.88; 3.86; 3.86 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline |
1.89; 2.46; 2.59; 2.63; 2.59 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2 |
0.61; 0.75; 0.74; 0.74 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline |
1.43; 2.00; 2.25; 2.26; 2.28 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2 |
0.55; 0.81; 0.83; 0.83 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline |
3.18; 4.38; 4.73; 4.70; 4.72 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2 |
1.20; 1.54; 1.54; 1.54 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline |
2.73; 3.67; 3.92; 3.91; 3.89 | <0.001 sig |
| SECONDARY International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2 |
0.97; 1.21; 1.20; 1.20 | <0.001 sig |
| SECONDARY Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline |
32.71; 46.21; 45.53; 45.28; 45.05 | <0.001 sig |
| SECONDARY Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2 |
13.84; 13.07; 12.69; 12.69 | <0.001 sig |
| SECONDARY Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline |
5.41; 8.85; 9.21; 9.28; 9.25 | <0.001 sig |
| SECONDARY Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2 |
3.51; 3.91; 3.91; 3.91 | <0.001 sig |
| SECONDARY Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline |
6.68; 9.94; 10.59; 10.63; 10.64 | <0.001 sig |
| SECONDARY Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2 |
3.29; 4.03; 4.01; 4.01 | <0.001 sig |
| SECONDARY Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline |
2.79; 4.23; 4.74; 4.78; 4.76 | <0.001 sig |
| SECONDARY Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2 |
1.49; 1.96; 1.98; 1.98 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline |
8.84; 10.18; 12.29; 11.96; 11.95 | 0.0016 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2 |
1.37; 3.12; 2.98; 3.04 | 0.3324 |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline |
15.37; 17.15; 18.22; 17.33; 17.68 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2 |
1.46; 1.18; 1.13; 1.15 | 0.1061 |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline |
56.96; 70.78; 71.23; 72.15; 71.60 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2 |
13.56; 14.25; 14.51; 14.77 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline |
58.58; 76.29; 77.69; 78.79; 78.36 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2 |
17.90; 19.50; 19.52; 19.88 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline |
57.34; 70.72; 70.63; 72.07; 71.51 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2 |
13.10; 14.11; 13.47; 13.72 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline |
56.96; 70.78; 71.23; 72.15; 71.60 | <0.001 sig |
| SECONDARY 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 |
13.56; 14.25; 14.51; 14.77 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline |
-12.58; -20.55; -22.53; -21.44; -21.86 | 0.0010 sig |
| SECONDARY Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2 |
-6.79; -6.85; -7.43; -7.57 | 0.0021 sig |
| SECONDARY Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline |
-9.87; -11.74; -12.78; -13.13; -12.40 | 0.0045 sig |
| SECONDARY Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 |
-2.39; -1.91; -2.71; -2.76 | 0.2567 |
| SECONDARY Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline |
-10.82; -29.16; -30.79; -30.27; -30.87 | 0.0558 |
| SECONDARY Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 |
-18.36; -22.16; -20.28; -20.65 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline |
33.27; 61.45; 66.10; 64.84; 65.13 | <0.001 sig |
| SECONDARY Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2 |
27.53; 30.92; 30.43; 30.98 | <0.001 sig |
| SECONDARY 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 |
22.45; 32.30; 35.31; 34.57; 34.26 | <0.001 sig |
| SECONDARY 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 |
9.18; 8.75; 10.15; 10.33 | 0.0014 sig |
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 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.
Data sourced from ClinicalTrials.gov (NCT00468650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.