To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.
placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks
Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Laguna Woods, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.
Time frame: Week 12
International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients
Time frame: Week 8 and Week 12
Self-Esteem and Relationship Questionnaire (SEAR) in ED patients
Time frame: Week 12
ED Subject Event Log in ED patients
Time frame: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients
Time frame: Week 12
Dyadic Adjustment Scale (DAS) in ED patients
Time frame: Week 8 and Week 12
American Urological Association (AUA) Symptom Index in ED patients
Time frame: Week 12
Global Efficacy Assessment Questions (GEQ) in ED patients
Time frame: Week 12
Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners
Time frame: Week 8 and Week 12
Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners
Time frame: Week 12
Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners
Time frame: Week 12
Partner EDITS in female partners
Time frame: Week 12
Female Partner Treatment Continuation Question in female partners
Time frame: Week 12
Dyadic Adjustment Scale (DAS) in female partners
Time frame: Week 8 and Week 12
Beck Depression Inventory (BDI-II) in female partners
Time frame: Week 12
Female Partner Event Log in female partners
Time frame: Week 12
AUA Symptom Index in female partners
Time frame: Week 12
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Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Torrance, California, United States
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Aurora, Colorado, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
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