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Clinical Trials/NCT00468650
NCT00468650CompletedPhase 4

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.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country117 target enrollmentStarted: June 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
117
Locations
1
Primary Endpoint
International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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
  • •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.

Arms & Interventions

Open label

Active Comparator

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.

Intervention: sildenafil citrate (Drug)

Outcomes

Primary Outcomes

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

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 Outcomes

  • International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2(Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6(Week 2, Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2(Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline(Week 2, Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2(Week 4 and Week 6)
  • Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline(Week 2, Week 4 and Week 6)
  • Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2(Week 4 and Week 6)
  • Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline(Week 2, Week 4, and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline(Week 2, Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline(Week 2, Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2(Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline(Week 2, Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline(Week 2, Week 4, and Week 6)
  • International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline(Week 2, Week 4 and Week 6)
  • International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2(Week 4 and Week 6)
  • Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline(Week 2, Week 4, and Week 6)
  • Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2(Week 4 and Week 6)
  • Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2(Week 4 and Week 6)
  • Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline(Week 2, Week 4, and Week 6)
  • Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline(Week 2, Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline(Week 2, Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline(Week 2, Week 4 and Week 6)
  • 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(Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline(Week 2, Week 4, and Week 6)
  • Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline(Week 2, Week 4 and Week 6)
  • Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline(Week 2, Week 4 and Week 6)
  • Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline(Week 2, Week 4 and Week 6)
  • Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2(Week 4 and Week 6)
  • Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline(Week 2, Week 4 and Week 6)
  • Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2(Week 4 and Week 6)
  • 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(Week 2, Week 4 and Week 6)
  • 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(Week 4 and Week 6)

Investigators

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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