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
- Registration Number
- NCT00644631
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 placebo - Arm 1 sildenafil -
- Primary Outcome Measures
Name Time Method Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners. Week 12
- Secondary Outcome Measures
Name Time Method Self-Esteem and Relationship Questionnaire (SEAR) in ED patients Week 12 Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients Week 12 Beck Depression Inventory (BDI-II) in female partners Week 12 International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients Week 8 and Week 12 Dyadic Adjustment Scale (DAS) in ED patients Week 8 and Week 12 Global Efficacy Assessment Questions (GEQ) in ED patients Week 12 Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners Week 8 and Week 12 Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners Week 12 Partner EDITS in female partners Week 12 Female Partner Treatment Continuation Question in female partners Week 12 AUA Symptom Index in female partners Week 12 American Urological Association (AUA) Symptom Index in ED patients Week 12 Dyadic Adjustment Scale (DAS) in female partners Week 8 and Week 12 Female Partner Event Log in female partners Week 12 ED Subject Event Log in ED patients Week 12 Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners Week 12
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Spokane, Washington, United States