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NCT00644631 Clinical Trial

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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00644631
Other study ID # A1481177
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2003
Est. completion date April 2004

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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
placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks

Locations
Country Name City State
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Beachwood Ohio
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Des Moines Iowa
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Garden City New York
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Jeffersonville Indiana
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site Lacey Washington
United States Pfizer Investigational Site Laguna Woods California
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newtown Pennsylvania
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Palo Alto California
United States Pfizer Investigational Site Peabody Massachusetts
United States Pfizer Investigational Site Peoria Illinois
United States Pfizer Investigational Site Poughkeepsie New York
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners. Week 12
Secondary International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients Week 8 and Week 12
Secondary Self-Esteem and Relationship Questionnaire (SEAR) in ED patients Week 12
Secondary ED Subject Event Log in ED patients Week 12
Secondary Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients Week 12
Secondary Dyadic Adjustment Scale (DAS) in ED patients Week 8 and Week 12
Secondary American Urological Association (AUA) Symptom Index in ED patients Week 12
Secondary Global Efficacy Assessment Questions (GEQ) in ED patients Week 12
Secondary Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners Week 8 and Week 12
Secondary Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners Week 12
Secondary Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners Week 12
Secondary Partner EDITS in female partners Week 12
Secondary Female Partner Treatment Continuation Question in female partners Week 12
Secondary Dyadic Adjustment Scale (DAS) in female partners Week 8 and Week 12
Secondary Beck Depression Inventory (BDI-II) in female partners Week 12
Secondary Female Partner Event Log in female partners Week 12
Secondary AUA Symptom Index in female partners Week 12
See also
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Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4

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