Clinical trial NCT00648596: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 780
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in the Self-esteem domain of the SEAR questionnaire
timeFrame: Week 12
Secondary outcomes:
measure: 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
timeFrame: Week 12
measure: Differences in the global efficacy assessment question overall and by type of co-morbidity
timeFrame: Week 12
measure: Differences in the global satisfaction assessment questions overall and by type of co-morbidity
timeFrame: Week 12
measure: Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression)
timeFrame: Week 12
measure: Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity
timeFrame: Week 12
measure: Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity
timeFrame: Week 12
measure: Changes of the SEAR questions overall and by type of co-morbidity
timeFrame: Week 12
measure: Changes of the IIEF questions overall and by type of co-morbidity
timeFrame: Week 12
measure: Changes of the IIEF domains overall and by type of co-morbidity
timeFrame: Week 12
measure: Degrees of severity in the IIEF erectile function
timeFrame: Week 12
measure: 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
timeFrame: Week 12
measure: Changes in the questions from the event log overall and by type of co-morbidity
timeFrame: Week 12
measure: 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
timeFrame: Week 12
measure: Differences in the intercourse success rates derived from the event log overall and by type of comorbidity
timeFrame: Week 12
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Clermont Ferrand
country: France
facility: Pfizer Investigational Site
city: LE Kremlin Bicentre
country: France
facility: Pfizer Investigational Site
city: Lyon Cedex 03
country: France
facility: Pfizer Investigational Site
city: MARSEILLE Cedex 20
country: France
facility: Pfizer Investigational Site
city: Neuilly-sur-seine
country: France
facility: Pfizer Investigational Site
city: NICE Cedex 01
country: France
facility: Pfizer Investigational Site
city: Nimes
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Gallarate (VA)
country: Italy
facility: Pfizer Investigational Site
city: Modena
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Olsztyn
country: Poland
facility: Pfizer Investigational Site
city: Szczecin
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Barnaul
country: Russian Federation
facility: Pfizer Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: Pfizer Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Rostov-on-don
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: San Juan
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Barakaldo
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Karlshamn
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Varnamo
country: Sweden
facility: Pfizer Investigational Site
city: Vastervik
country: Sweden
facility: Pfizer Investigational Site
city: Bodelwyddan
country: United Kingdom
facility: Pfizer Investigational Site
state: Denbighshire
city: South Yorkshire
country: United Kingdom
facility: Pfizer Investigational Site
state: Dn1 2et
city: Belmont
country: United Kingdom
facility: Pfizer Investigational Site
state: Durham
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Urmston
country: United Kingdom
facility: Pfizer Investigational Site
state: Manchester
city: Ashford
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Nr Lichfield
country: United Kingdom
facility: Pfizer Investigational Site
state: Staffordshire
city: Addlestone
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Taunton
country: United Kingdom
facility: Pfizer Investigational Site
state: Ta1 5da
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: