Phase 4 N=176 Randomized Double-blind Treatment

Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied

Impotence

Bottom Line

View on ClinicalTrials.gov: NCT00301262 ↗

Enrolled (actual)

176

Serious AEs

—

Results posted

Dec 2008

Primary outcome: Primary: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8) — 80.27; 62.15 scores on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Viagra (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: Sep 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)	80.27; 62.15	<0.0001 sig
SECONDARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index	79.21; 84.12; 61.64; 87.42	0.0028 sig
SECONDARY Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score	3.97; 2.21	0.0080 sig
SECONDARY Patient Reported Erectile Function Assessment (PREFA) Total Score	28.54; 29.58; 26.79; 29.73	0.0051 sig
SECONDARY Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function	2.08; -0.53	0.0054 sig
SECONDARY Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function	0.59; 0.30	0.4232
SECONDARY Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire	0.60; -0.08	0.0156 sig
SECONDARY Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction	2.20; 1.00	0.0096 sig
SECONDARY Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction	2.35; 1.46	0.0135 sig
SECONDARY International Index of Erectile Function (IIEF) Domain Scores- Erectile Function	24.92; 26.43; 22.40; 27.67	0.0033 sig
SECONDARY International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function	8.62; 8.95; 7.81; 9.21	0.2581
SECONDARY International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire	7.90; 8.10; 7.37; 8.18	0.2857
SECONDARY International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction	11.82; 12.64; 10.84; 13.12	0.0102 sig
SECONDARY International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction	8.19; 8.94; 7.25; 9.12	0.0016 sig
SECONDARY Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score	5.14; 2.36	0.0083 sig
SECONDARY Erectile Distress Scale (EDS) Total Score	24.58; 24.55; 21.23; 26.58	0.9146
SECONDARY Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score	24.04; 5.62	0.0002 sig
SECONDARY Quality of Erection Questionnaire (QEQ) Total Score	80.20; 86.46; 63.64; 89.74	0.0064 sig
SECONDARY 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)	81.8; 43.8; 90.0; 94.0; 18.2; 56.2	0.0001 sig
SECONDARY 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)	79.3; 45.2; 86.3; 92.5; 20.7; 54.8	<0.0001 sig
SECONDARY 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)	94.3; 81.7; 95.0; 98.5; 5.7; 18.3	0.0187 sig
SECONDARY Percentage of Occasions of Successful Intercourse (Event Log)	79.65; 87.63	0.0427 sig
SECONDARY Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)	74.31; 64.60	0.0321 sig
SECONDARY Percentage of Occasions of Successful Intercourse (Event Log)	79.65; 87.63	0.0427 sig
SECONDARY Percentage of Occasions of Ejaculation and/or Orgasm Event Log	77.69; 85.29	0.0533
SECONDARY Change From Baseline to Week 8 in Analog Scales- Firmness	1.55; 0.38	0.0002 sig
SECONDARY Change From Baseline to Week 8 in Analog Scales- Maintenance	1.84; 0.40	0.0001 sig
SECONDARY Change From Baseline to Week 8 in Analog Scales- Reliability	1.61; 0.42	0.0032 sig
SECONDARY Change From Baseline to Week 8 in Analog Scales- General Sexual Performance	1.72; 0.51	0.0008 sig
SECONDARY Analog Scales- Firmness	7.87; 8.25; 6.60; 8.64	0.0195 sig
SECONDARY Analog Scales- Maintenance	7.65; 8.01; 5.99; 8.55	0.0186 sig
SECONDARY Analog Scales- Reliability	7.35; 7.96; 6.04; 8.55	0.0033 sig
SECONDARY Analog Scales- General Sexual Performance	7.58; 8.01; 6.53; 8.49	0.0143 sig
SECONDARY Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1	61; 27; 3; 0; 11; 36	0.0325 sig
SECONDARY Shift in Responder Rate From Week 8 to Week 14 for GEQ2	60; 29; 1; 0; 8; 33	0.0196 sig
SECONDARY Shift in Responder Rate From Week 8 to Week 14 for GEQ3	74; 54; 0; 0; 1; 10	0.3173
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0	7.09; 12.64; 4.50; 3.12	0.0624
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1	3.83; 6.31; 3.48; 1.88	0.2081
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2	6.96; 8.72; 4.62; 2.26	0.4069
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3	34.94; 47.17; 29.50; 30.12	0.0123 sig
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4	47.19; 25.16; 57.89; 62.63	<0.0001 sig
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4	82.13; 72.33; 87.39; 92.75	0.0257 sig
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0	0.00; 3.18; 0.13; 2.17	0.0726
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1	6.43; 7.47; 1.70; 2.03	0.8158
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2	14.93; 15.27; 11.96; 12.66	0.9529
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3	37.41; 47.59; 42.97; 33.29	0.2001
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4	41.23; 26.49; 43.24; 49.86	0.0606
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4	78.64; 74.08; 86.21; 83.14	0.5429
SECONDARY Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections	38.06; 19.20; 44.07; 39.15	0.0002 sig

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00301262). 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.