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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States, 90212
        • Pfizer Investigational Site
      • Laguna Woods, California, United States, 92653
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90073
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Palo Alto, California, United States, 94305
        • Pfizer Investigational Site
      • Torrance, California, United States, 90505
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Florida
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Pfizer Investigational Site
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Pfizer Investigational Site
    • New York
      • Garden City, New York, United States, 11530
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Pfizer Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122-5402
        • Pfizer Investigational Site
    • Pennsylvania
      • Newtown, Pennsylvania, United States, 18940
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Washington
      • Lacey, Washington, United States, 98516
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98105
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99207
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 2
Drug: placebo
placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 8 and Week 12
Self-Esteem and Relationship Questionnaire (SEAR) in ED patients
Time Frame: Week 12
Week 12
ED Subject Event Log in ED patients
Time Frame: Week 12
Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients
Time Frame: Week 12
Week 12
Dyadic Adjustment Scale (DAS) in ED patients
Time Frame: Week 8 and Week 12
Week 8 and Week 12
American Urological Association (AUA) Symptom Index in ED patients
Time Frame: Week 12
Week 12
Global Efficacy Assessment Questions (GEQ) in ED patients
Time Frame: Week 12
Week 12
Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners
Time Frame: Week 8 and Week 12
Week 8 and Week 12
Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners
Time Frame: Week 12
Week 12
Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners
Time Frame: Week 12
Week 12
Partner EDITS in female partners
Time Frame: Week 12
Week 12
Female Partner Treatment Continuation Question in female partners
Time Frame: Week 12
Week 12
Dyadic Adjustment Scale (DAS) in female partners
Time Frame: Week 8 and Week 12
Week 8 and Week 12
Beck Depression Inventory (BDI-II) in female partners
Time Frame: Week 12
Week 12
Female Partner Event Log in female partners
Time Frame: Week 12
Week 12
AUA Symptom Index in female partners
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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