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Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
This study has been completed.
Study NCT00301262   Information provided by Pfizer
First Received: March 7, 2006   Last Updated: December 8, 2008   History of Changes

March 7, 2006
December 8, 2008
November 2005
 
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • with mild erectile dysfunction who are sexually dissatisfied, as measured by the
  • Erectile Dysfunction Inventory of Treatment Satisfaction at the end of the double-
  • Measure the impact of treatment with VIAGRA on the treatment satisfaction in men
  • blind treatment.
Complete list of historical versions of study NCT00301262 on ClinicalTrials.gov Archive Site
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Analog Scales- Maintenance [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- Reliability [ Time Frame: baseline to Week 8 ] [ Designated as safety issue: No ]
  • Analog Scales- Firmness [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Shift in Responder Rate From Week 8 to Week 14 for GEQ3 [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Successful Intercourse (Event Log) [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Erectile Function [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Analog Scales- General Sexual Performance [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Successful Intercourse (Event Log) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • Analog Scales- Reliability [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1 [ Time Frame: Baseline to <= Week 14 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Erectile Distress Scale (EDS) Total Score [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Quality of Erection Questionnaire (QEQ) Total Score [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- Firmness [ Time Frame: baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- General Sexual Performance [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- Maintenance [ Time Frame: baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Shift in Responder Rate From Week 8 to Week 14 for GEQ2 [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4 [ Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14 ] [ Designated as safety issue: No ]
  • Patient Reported Erectile Function Assessment (PREFA) Total Score [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Measure Viagra's effect on the Patient Reported Erectile Function Assessment; measure Viagra's effect on the erectile function parameters; measure treatment's
  • effect on degree of bother; examine correlation between degree of bother and International Index of Erectile Function & Quality of Life; report Viagra's safety in this patient population.
 
Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction

Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Impotence
Drug: Viagra (Sildenafil citrate)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
183
 
 

Inclusion Criteria:

  • Men above age of majority
  • Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)

Exclusion Criteria:

  • Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
  • Subjects currently taking any other commercially available drug or non-drug treatment for ED
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00301262
 
A1481238
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP