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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: sildenafil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: sildenafil<br>* 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.<br>|
| Placebo Comparator: Arm 2<br> | Drug: placebo<br>* placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| American Urological Association (AUA) Symptom Index in ED patients |  | 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 | 
| Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners |  | 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 | 
| Dyadic Adjustment Scale (DAS) in female partners |  | Week 8 and Week 12 | 
| Beck Depression Inventory (BDI-II) in female partners |  | Week 12 | 
| Female Partner Event Log in female partners |  | Week 12 | 
| AUA Symptom Index in female partners |  | Week 12 |