Clinical trial NCT00644631: A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate
Official title: A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate) In The United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The male patient must have had a documented clinical diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of less than or equal to 21
* a stable female partner at least 21 years of age for at least 6 months prior to screening
* the couple must have been married or living together at the time of screening.
* The female partner must have answered "no intercourse," "sometimes," "a few times" or "almost never" on Question 3 of the Female Partner of ED Subject Questionnaire (FePEDS-Q)

Exclusion Criteria:

* The male patient must not have had resting sitting and/or standing hypotension (BP \< 90/50mmHg) or hypertension (BP \> 170/110mmHg), or significant cardiovascular disease in the last 3 months, including cardiac failure, myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias.
* Female partners must not have had significant dyspareunia or lifelong significant sexual dysfunction based on female partner's medical and sexual history at screening.

Primary outcomes:
measure: Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.
timeFrame: Week 12
Secondary outcomes:
measure: International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients
timeFrame: Week 8 and Week 12
measure: Self-Esteem and Relationship Questionnaire (SEAR) in ED patients
timeFrame: Week 12
measure: ED Subject Event Log in ED patients
timeFrame: Week 12
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients
timeFrame: Week 12
measure: Dyadic Adjustment Scale (DAS) in ED patients
timeFrame: Week 8 and Week 12
measure: American Urological Association (AUA) Symptom Index in ED patients
timeFrame: Week 12
measure: Global Efficacy Assessment Questions (GEQ) in ED patients
timeFrame: Week 12
measure: Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners
timeFrame: Week 8 and Week 12
measure: Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners
timeFrame: Week 12
measure: Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners
timeFrame: Week 12
measure: Partner EDITS in female partners
timeFrame: Week 12
measure: Female Partner Treatment Continuation Question in female partners
timeFrame: Week 12
measure: Dyadic Adjustment Scale (DAS) in female partners
timeFrame: Week 8 and Week 12
measure: Beck Depression Inventory (BDI-II) in female partners
timeFrame: Week 12
measure: Female Partner Event Log in female partners
timeFrame: Week 12
measure: AUA Symptom Index in female partners
timeFrame: Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Woods
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Palo Alto
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Peabody
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Newtown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lacey
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: