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
  Purpose

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 Intervention Phase
Erectile Dysfunction
Drug: sildenafil
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 300
Study Start Date: June 2003
Study Completion Date: April 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644631

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644631     History of Changes
Other Study ID Numbers: A1481177
Study First Received: March 25, 2008
Last Updated: March 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014