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NCT00648596 Clinical Trial

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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00648596
Other study ID # A1481161
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2003
Est. completion date May 2004

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 780
Est. completion date May 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• placebo
placebo tablet by mouth 1 hour before sexual activity for 12 weeks

Locations
Country Name City State
Finland Pfizer Investigational Site Oulu
Finland Pfizer Investigational Site Tampere
Finland Pfizer Investigational Site Turku
France Pfizer Investigational Site Clermont Ferrand
France Pfizer Investigational Site LE Kremlin Bicentre
France Pfizer Investigational Site Lyon Cedex 03
France Pfizer Investigational Site MARSEILLE Cedex 20
France Pfizer Investigational Site Neuilly-sur-seine
France Pfizer Investigational Site NICE Cedex 01
France Pfizer Investigational Site Nimes
France Pfizer Investigational Site Toulouse
Italy Pfizer Investigational Site Bari
Italy Pfizer Investigational Site Catania
Italy Pfizer Investigational Site Gallarate (VA)
Italy Pfizer Investigational Site Modena
Italy Pfizer Investigational Site Padova
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Siena
Italy Pfizer Investigational Site Torino
Poland Pfizer Investigational Site 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
Russian Federation Pfizer Investigational Site Barnaul
Russian Federation Pfizer Investigational Site Ekaterinburg
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Nizhny Novgorod
Russian Federation Pfizer Investigational Site Novosibirsk
Russian Federation Pfizer Investigational Site Novosibirsk
Russian Federation Pfizer Investigational Site Rostov-on-don
Russian Federation Pfizer Investigational Site Saint-Petersburg
Russian Federation Pfizer Investigational Site Saint-Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Spain Pfizer Investigational Site Barakaldo Vizcaya
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site San Juan Alicante
Spain Pfizer Investigational Site Valencia
Spain Pfizer Investigational Site Valencia
Spain Pfizer Investigational Site Zaragoza
Sweden Pfizer Investigational Site Karlshamn
Sweden Pfizer Investigational Site Malmo
Sweden Pfizer Investigational Site Skovde
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Varnamo
Sweden Pfizer Investigational Site Vastervik
United Kingdom Pfizer Investigational Site Addlestone Surrey
United Kingdom Pfizer Investigational Site Ashford Middlesex
United Kingdom Pfizer Investigational Site Belmont Durham
United Kingdom Pfizer Investigational Site Blackpool Lancashire
United Kingdom Pfizer Investigational Site Bodelwyddan Denbighshire
United Kingdom Pfizer Investigational Site Nr Lichfield Staffordshire
United Kingdom Pfizer Investigational Site South Yorkshire Dn1 2et
United Kingdom Pfizer Investigational Site Taunton Ta1 5da
United Kingdom Pfizer Investigational Site Urmston Manchester

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Finland,  France,  Italy,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the Self-esteem domain of the SEAR questionnaire Week 12
Secondary 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 Week 12
Secondary Differences in the global efficacy assessment question overall and by type of co-morbidity Week 12
Secondary Differences in the global satisfaction assessment questions overall and by type of co-morbidity Week 12
Secondary Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression) Week 12
Secondary Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity Week 12
Secondary Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity Week 12
Secondary Changes of the SEAR questions overall and by type of co-morbidity Week 12
Secondary Changes of the IIEF questions overall and by type of co-morbidity Week 12
Secondary Changes of the IIEF domains overall and by type of co-morbidity Week 12
Secondary Degrees of severity in the IIEF erectile function Week 12
Secondary 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 Week 12
Secondary Changes in the questions from the event log overall and by type of co-morbidity Week 12
Secondary 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 Week 12
Secondary Differences in the intercourse success rates derived from the event log overall and by type of comorbidity Week 12
See also
  Status Clinical Trial Phase
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Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4

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