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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00648596
First Posted: April 1, 2008
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

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 ]
  • Differences in the global efficacy assessment question overall and by type of co-morbidity [ Time Frame: Week 12 ]
  • Differences in the global satisfaction assessment questions overall and by type of co-morbidity [ Time Frame: 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) [ Time Frame: Week 12 ]
  • Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity [ Time Frame: Week 12 ]
  • Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity [ Time Frame: Week 12 ]
  • Changes of the SEAR questions overall and by type of co-morbidity [ Time Frame: Week 12 ]
  • Changes of the IIEF questions overall and by type of co-morbidity [ Time Frame: Week 12 ]
  • Changes of the IIEF domains overall and by type of co-morbidity [ Time Frame: Week 12 ]
  • Degrees of severity in the IIEF erectile function [ Time Frame: 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 [ Time Frame: Week 12 ]
  • Changes in the questions from the event log overall and by type of co-morbidity [ Time Frame: 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 [ Time Frame: Week 12 ]
  • Differences in the intercourse success rates derived from the event log overall and by type of comorbidity [ Time Frame: Week 12 ]

Enrollment: 780
Study Start Date: May 2003
Study Completion Date: May 2004
Arms Assigned Interventions
Placebo Comparator: Arm 2 Drug: placebo
placebo tablet by mouth 1 hour before sexual activity for 12 weeks
Active Comparator: Arm 1 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00648596


  Show 67 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00648596     History of Changes
Other Study ID Numbers: A1481161
First Submitted: March 27, 2008
First Posted: April 1, 2008
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents