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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014