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
NCT ID: NCT00644631
Last Updated: 2021-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2003-06-30
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
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.
Arm 2
placebo
placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Female partners must not have had significant dyspareunia or lifelong significant sexual dysfunction based on female partner's medical and sexual history at screening.
21 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Laguna Woods, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Jeffersonville, Indiana, United States
Pfizer Investigational Site
Des Moines, Iowa, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Peabody, Massachusetts, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Garden City, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Poughkeepsie, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Beachwood, Ohio, United States
Pfizer Investigational Site
Newtown, Pennsylvania, United States
Pfizer Investigational Site
Knoxville, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Lacey, Washington, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Spokane, Washington, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1481177
Identifier Type: -
Identifier Source: org_study_id
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