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

NCT00644631 | Completed Phase 4

• 1 other identifier: A1481177
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 31

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.

  Week 12

Secondary Outcomes (16)

• International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients

  Week 8 and Week 12

• Self-Esteem and Relationship Questionnaire (SEAR) in ED patients

  Week 12

• ED Subject Event Log in ED patients

  Week 12

• Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients

  Week 12

• Dyadic Adjustment Scale (DAS) in ED patients

  Week 8 and Week 12

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: sildenafil

Arm 2

PLACEBO COMPARATOR

Drug: placebo

Interventions

sildenafil DRUG

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 1

placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (31)

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, United States

Location

Pfizer Investigational Site

Beverly Hills, California, 90212, United States

Location

Pfizer Investigational Site

Laguna Woods, California, 92653, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90073, United States

Location

Pfizer Investigational Site

Palo Alto, California, 94305, United States

Location

Pfizer Investigational Site

Torrance, California, 90505, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80012, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34474, United States

Location

Pfizer Investigational Site

Peoria, Illinois, 61614, United States

Location

Pfizer Investigational Site

Jeffersonville, Indiana, 47130, United States

Location

Pfizer Investigational Site

Des Moines, Iowa, 50314, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66215, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21204, United States

Location

Pfizer Investigational Site

Peabody, Massachusetts, 01960, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63117, United States

Location

Pfizer Investigational Site

Garden City, New York, 11530, United States

Location

Pfizer Investigational Site

New York, New York, 10016, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Poughkeepsie, New York, 12601, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27705, United States

Location

Pfizer Investigational Site

Beachwood, Ohio, 44122-5402, United States

Location

Pfizer Investigational Site

Newtown, Pennsylvania, 18940, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37920, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Lacey, Washington, 98516, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98105, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99207, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 27, 2008
• Study Start: June 1, 2003
• Study Completion: April 1, 2004
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (31)