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

NCT ID: NCT00648596

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Arm 1

Group Type ACTIVE_COMPARATOR

sildenafil

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Oulu, , Finland

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Tampere, , Finland

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Turku, , Finland

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Clermont-Ferrand, , France

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LE Kremlin Bicentre, , France

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Lyon, , France

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Marseille, , France

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Neuilly-sur-Seine, , France

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Nice, , France

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Nîmes, , France

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Toulouse, , France

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Bari, , Italy

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Catania, , Italy

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Gallarate (VA), , Italy

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Modena, , Italy

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Padua, , Italy

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Roma, , Italy

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Siena, , Italy

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Torino, , Italy

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Barnaul, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Yekaterinburg, , Russia

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San Juan, Alicante, Spain

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Barakaldo, Vizcaya, Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Karlshamn, , Sweden

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Malmo, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Värnamo, , Sweden

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Västervik, , Sweden

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Bodelwyddan, Denbighshire, United Kingdom

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South Yorkshire, DN1 2ET, United Kingdom

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Belmont, Durham, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Urmston, Manchester, United Kingdom

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Ashford, Middlesex, United Kingdom

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Nr Lichfield, Staffordshire, United Kingdom

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Addlestone, Surrey, United Kingdom

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Taunton, TA1 5DA, United Kingdom

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Countries

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Finland France Italy Poland Russia Spain Sweden United Kingdom

Related Links

Other Identifiers

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A1481161

Identifier Type: -

Identifier Source: org_study_id

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