Status:
COMPLETED
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
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Erectile Dysfunction
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2004
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00644631
Start Date
June 1 2003
End Date
April 1 2004
Last Update
February 1 2021
Active Locations (31)
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1
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
2
Pfizer Investigational Site
Little Rock, Arkansas, United States
3
Pfizer Investigational Site
Beverly Hills, California, United States, 90212
4
Pfizer Investigational Site
Laguna Woods, California, United States, 92653