search
Back to results

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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
sildenafil
placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm 2

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the Self-esteem domain of the SEAR questionnaire

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
Differences in the global efficacy assessment question overall and by type of co-morbidity
Differences in the global satisfaction assessment questions overall and by type of co-morbidity
Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression)
Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity
Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity
Changes of the SEAR questions overall and by type of co-morbidity
Changes of the IIEF questions overall and by type of co-morbidity
Changes of the IIEF domains overall and by type of co-morbidity
Degrees of severity in the IIEF erectile function
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
Changes in the questions from the event log overall and by type of co-morbidity
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
Differences in the intercourse success rates derived from the event log overall and by type of comorbidity

Full Information

First Posted
March 27, 2008
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00648596
Brief Title
A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
780 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Title
Arm 1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet by mouth 1 hour before sexual activity for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the Self-esteem domain of the SEAR questionnaire
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
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
Title
Differences in the global efficacy assessment question overall and by type of co-morbidity
Time Frame
Week 12
Title
Differences in the global satisfaction assessment questions overall and by type of co-morbidity
Time Frame
Week 12
Title
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
Title
Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity
Time Frame
Week 12
Title
Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity
Time Frame
Week 12
Title
Changes of the SEAR questions overall and by type of co-morbidity
Time Frame
Week 12
Title
Changes of the IIEF questions overall and by type of co-morbidity
Time Frame
Week 12
Title
Changes of the IIEF domains overall and by type of co-morbidity
Time Frame
Week 12
Title
Degrees of severity in the IIEF erectile function
Time Frame
Week 12
Title
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
Title
Changes in the questions from the event log overall and by type of co-morbidity
Time Frame
Week 12
Title
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
Title
Differences in the intercourse success rates derived from the event log overall and by type of comorbidity
Time Frame
Week 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20110
Country
Finland
Facility Name
Pfizer Investigational Site
City
Clermont Ferrand
ZIP/Postal Code
63023
Country
France
Facility Name
Pfizer Investigational Site
City
LE Kremlin Bicentre
ZIP/Postal Code
94275
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
MARSEILLE Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Pfizer Investigational Site
City
Neuilly-sur-seine
ZIP/Postal Code
92200
Country
France
Facility Name
Pfizer Investigational Site
City
NICE Cedex 01
ZIP/Postal Code
06002
Country
France
Facility Name
Pfizer Investigational Site
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Pfizer Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Gallarate (VA)
ZIP/Postal Code
21013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Krakow
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lublin
Country
Poland
Facility Name
Pfizer Investigational Site
City
Olsztyn
Country
Poland
Facility Name
Pfizer Investigational Site
City
Szczecin
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
Country
Poland
Facility Name
Pfizer Investigational Site
City
Barnaul
ZIP/Postal Code
656099
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
123448
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125206
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
127411
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Novosibirsk
ZIP/Postal Code
630003
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Rostov-on-don
ZIP/Postal Code
344068
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
193318
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
San Juan
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Karlshamn
ZIP/Postal Code
374 35
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Skovde
ZIP/Postal Code
541 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Varnamo
ZIP/Postal Code
331 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Vastervik
ZIP/Postal Code
593 81
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bodelwyddan
State/Province
Denbighshire
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
South Yorkshire
State/Province
Dn1 2et
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Belmont
State/Province
Durham
ZIP/Postal Code
DH1 2QP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY4 3AD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Urmston
State/Province
Manchester
ZIP/Postal Code
M41 0UH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ashford
State/Province
Middlesex
ZIP/Postal Code
TW15 3EA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Nr Lichfield
State/Province
Staffordshire
ZIP/Postal Code
WS14 9JL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Addlestone
State/Province
Surrey
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Taunton
State/Province
Ta1 5da
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481161&StudyName=An%20international%2C%20multicentre%2C%20randomized%2C%20parallel%20group%2C%20double%20blind%2C%20placebo%20controlled%2C%20flexible%20dose%20study%20to%20evaluate%20self-es
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs