A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

Study Overview
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Brief Summary
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To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function [EF] domain of the International Index of Erectile Function [IIEF]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.

Official Title
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An International, Multicentre, Randomized, Parallel Group, Double Blind, Placebo Controlled, Flexible Dose Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfunction Treated With Sildenafil Citrate

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: -Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included. Exclusion Criteria: Subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months Subjects with resting sitting hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg) Subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias in the last 3 months Patients on nitrates.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: placebo<br>* placebo tablet by mouth 1 hour before sexual activity for 12 weeks<br>|
| Active Comparator: Arm 1<br> | Drug: sildenafil<br>* sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Self-esteem domain of the SEAR questionnaire |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF by number of ED co-morbidities |  | Week 12 | 
| Differences in the global efficacy assessment question overall and by type of co-morbidity |  | Week 12 | 
| Differences in the global satisfaction assessment questions overall and by type of co-morbidity |  | Week 12 | 
| Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression) |  | Week 12 | 
| Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity |  | Week 12 | 
| Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity |  | Week 12 | 
| Changes of the SEAR questions overall and by type of co-morbidity |  | Week 12 | 
| Changes of the IIEF questions overall and by type of co-morbidity |  | Week 12 | 
| Changes of the IIEF domains overall and by type of co-morbidity |  | Week 12 | 
| Degrees of severity in the IIEF erectile function |  | Week 12 | 
| Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF overall and by type of co-morbidity |  | Week 12 | 
| Changes in the questions from the event log overall and by type of co-morbidity |  | Week 12 | 
| Correlation between each success rate derived from the event log and the change in the SE domain of the SEAR questionnaire overall and by type of co-morbidity |  | Week 12 | 
| Differences in the intercourse success rates derived from the event log overall and by type of comorbidity |  | Week 12 |