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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00648596
First received: March 27, 2008
Last updated: April 2, 2008
Last verified: April 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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
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

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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014