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”

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.

Intervention(s) in this Clinical Trial

• Drug: sildenafil
  • 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.
• Drug: placebo
  • placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• Self-Esteem and Relationship Questionnaire (SEAR) in ED patients
  • Time Frame: Week 12
    Safety Issue?: No
• ED Subject Event Log in ED patients
  • Time Frame: Week 12
    Safety Issue?: No
• Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients
  • Time Frame: Week 12
    Safety Issue?: No
• Dyadic Adjustment Scale (DAS) in ED patients
  • Time Frame: Week 8 and Week 12
    Safety Issue?: No
• American Urological Association (AUA) Symptom Index in ED patients
  • Time Frame: Week 12
    Safety Issue?: No
• Global Efficacy Assessment Questions (GEQ) in ED patients
  • Time Frame: Week 12
    Safety Issue?: No
• Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners
  • Time Frame: Week 8 and Week 12
    Safety Issue?: No
• Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners
  • Time Frame: Week 12
    Safety Issue?: No
• Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners
  • Time Frame: Week 12
    Safety Issue?: No
• Partner EDITS in female partners
  • Time Frame: Week 12
    Safety Issue?: No
• Female Partner Treatment Continuation Question in female partners
  • Time Frame: Week 12
    Safety Issue?: No
• Dyadic Adjustment Scale (DAS) in female partners
  • Time Frame: Week 8 and Week 12
    Safety Issue?: No
• Beck Depression Inventory (BDI-II) in female partners
  • Time Frame: Week 12
    Safety Issue?: No
• Female Partner Event Log in female partners
  • Time Frame: Week 12
    Safety Issue?: No
• AUA Symptom Index in female partners
  • Time Frame: Week 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644631

Study ID Number: A1481177

ClinicalTrials.gov Identifier: NCT00644631

Health Authority: United States: Food and Drug Administration

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