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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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644631
First received: March 25, 2008
Last updated: March 26, 2008
Last verified: March 2008
March 25, 2008
March 26, 2008
June 2003
Not Provided
Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners. [ Time Frame: Week 12 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • 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
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2004
Not Provided

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00644631
A1481177
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

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