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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

780

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90100
        • Pfizer Investigational Site
      • Tampere, Finland
        • Pfizer Investigational Site
      • Turku, Finland, 20110
        • Pfizer Investigational Site
  • France
      • Clermont Ferrand, France, 63023
        • Pfizer Investigational Site
      • LE Kremlin Bicentre, France, 94275
        • Pfizer Investigational Site
      • Lyon Cedex 03, France, 69437
        • Pfizer Investigational Site
      • MARSEILLE Cedex 20, France, 13915
        • Pfizer Investigational Site
      • NICE Cedex 01, France, 06002
        • Pfizer Investigational Site
      • Neuilly-sur-seine, France, 92200
        • Pfizer Investigational Site
      • Nimes, France, 30029
        • Pfizer Investigational Site
      • Toulouse, France, 31403
        • Pfizer Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Pfizer Investigational Site
      • Catania, Italy, 95124
        • Pfizer Investigational Site
      • Gallarate (VA), Italy, 21013
        • Pfizer Investigational Site
      • Modena, Italy, 41100
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Roma, Italy, 00100
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
      • Torino, Italy, 10126
        • Pfizer Investigational Site
  • Poland
      • Krakow, Poland
        • Pfizer Investigational Site
      • Lodz, Poland
        • Pfizer Investigational Site
      • Lublin, Poland
        • Pfizer Investigational Site
      • Olsztyn, Poland
        • Pfizer Investigational Site
      • Szczecin, Poland
        • Pfizer Investigational Site
      • Warszawa, Poland
        • Pfizer Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656099
        • Pfizer Investigational Site
      • Ekaterinburg, Russian Federation
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 121552
        • Pfizer Investigational Site
      • Moscow, Russian Federation
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 125206
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 105425
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 117036
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 125101
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 123448
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 127411
        • Pfizer Investigational Site
      • Nizhny Novgorod, Russian Federation
        • Pfizer Investigational Site
      • Novosibirsk, Russian Federation, 630003
        • Pfizer Investigational Site
      • Novosibirsk, Russian Federation, 630087
        • Pfizer Investigational Site
      • Rostov-on-don, Russian Federation, 344068
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 193318
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 197089
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
      • Valencia, Spain, 46010
        • Pfizer Investigational Site
      • Zaragoza, Spain, 50009
        • Pfizer Investigational Site
    • Alicante
      • San Juan, Alicante, Spain, 03550
        • Pfizer Investigational Site
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Pfizer Investigational Site
  • Sweden
      • Karlshamn, Sweden, 374 35
        • Pfizer Investigational Site
      • Malmo, Sweden, 205 02
        • Pfizer Investigational Site
      • Skovde, Sweden, 541 30
        • Pfizer Investigational Site
      • Stockholm, Sweden, 171 76
        • Pfizer Investigational Site
      • Varnamo, Sweden, 331 85
        • Pfizer Investigational Site
      • Vastervik, Sweden, 593 81
        • Pfizer Investigational Site
  • United Kingdom
    • Denbighshire
      • Bodelwyddan, Denbighshire, United Kingdom, LL18 5UJ
        • Pfizer Investigational Site
    • Dn1 2et
      • South Yorkshire, Dn1 2et, United Kingdom
        • Pfizer Investigational Site
    • Durham
      • Belmont, Durham, United Kingdom, DH1 2QP
        • Pfizer Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY4 3AD
        • Pfizer Investigational Site
    • Manchester
      • Urmston, Manchester, United Kingdom, M41 0UH
        • Pfizer Investigational Site
    • Middlesex
      • Ashford, Middlesex, United Kingdom, TW15 3EA
        • Pfizer Investigational Site
    • Staffordshire
      • Nr Lichfield, Staffordshire, United Kingdom, WS14 9JL
        • Pfizer Investigational Site
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
        • Pfizer Investigational Site
    • Ta1 5da
      • Taunton, Ta1 5da, United Kingdom
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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