A Study to Evaluate Self-Esteem and Relationships in Males With Erectile Dysfuntion - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00648596

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: sildenafil Drug: placebo	Phase IV

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in the Self-esteem domain of the SEAR questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Differences in the global efficacy assessment question overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Differences in the global satisfaction assessment questions overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Changes of the SEAR questions overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Changes of the IIEF questions overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Changes of the IIEF domains overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Degrees of severity in the IIEF erectile function [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Changes in the questions from the event log overall and by type of co-morbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Differences in the intercourse success rates derived from the event log overall and by type of comorbidity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment:	780
Study Start Date:	May 2003
Study Completion Date:	May 2004

Arms	Assigned Interventions
Arm 2: Placebo Comparator	Drug: placebo placebo tablet by mouth 1 hour before sexual activity for 12 weeks
Arm 1: Active Comparator	Drug: sildenafil 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648596

Show 69 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481161
Study First Received:	March 27, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00648596
Health Authority:	Spain: Ethics Committee

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Citric Acid

Sildenafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Agents
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009