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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

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ClinicalTrials.gov Identifier: NCT00644631
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: sildenafil Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1 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.

Placebo Comparator: Arm 2 Drug: placebo
placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks




Primary Outcome Measures :
  1. Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners. [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Self-Esteem and Relationship Questionnaire (SEAR) in ED patients [ Time Frame: Week 12 ]
  3. ED Subject Event Log in ED patients [ Time Frame: Week 12 ]
  4. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients [ Time Frame: Week 12 ]
  5. Dyadic Adjustment Scale (DAS) in ED patients [ Time Frame: Week 8 and Week 12 ]
  6. American Urological Association (AUA) Symptom Index in ED patients [ Time Frame: Week 12 ]
  7. Global Efficacy Assessment Questions (GEQ) in ED patients [ Time Frame: Week 12 ]
  8. Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners [ Time Frame: Week 8 and Week 12 ]
  9. Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners [ Time Frame: Week 12 ]
  10. Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners [ Time Frame: Week 12 ]
  11. Partner EDITS in female partners [ Time Frame: Week 12 ]
  12. Female Partner Treatment Continuation Question in female partners [ Time Frame: Week 12 ]
  13. Dyadic Adjustment Scale (DAS) in female partners [ Time Frame: Week 8 and Week 12 ]
  14. Beck Depression Inventory (BDI-II) in female partners [ Time Frame: Week 12 ]
  15. Female Partner Event Log in female partners [ Time Frame: Week 12 ]
  16. AUA Symptom Index in female partners [ Time Frame: Week 12 ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644631


  Show 31 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644631     History of Changes
Other Study ID Numbers: A1481177
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Citric Acid
Sildenafil Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents