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

NCT00648596 | Completed Phase 4

• 1 other identifier: A1481161
• Study Type: interventional
• Target: 780
• Locations: 8 countries
• Sites: 66

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  Week 12

Secondary Outcomes (14)

• 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

• Differences in the global efficacy assessment question overall and by type of co-morbidity

  Week 12

• Differences in the global satisfaction assessment questions overall and by type of co-morbidity

  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)

  Week 12

• Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity

  Week 12

Study Arms (2)

Arm 2

PLACEBO COMPARATOR

Drug: placebo

Arm 1

ACTIVE COMPARATOR

Drug: sildenafil

Interventions

sildenafil 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.

Arm 1

placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (66)

Pfizer Investigational Site

Oulu, 90100, Finland

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Tampere, Finland

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Turku, 20110, Finland

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Clermont-Ferrand, 63023, France

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LE Kremlin Bicentre, 94275, France

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Lyon, 69437, France

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Marseille, 13915, France

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Neuilly-sur-Seine, 92200, France

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Nice, 06002, France

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Nîmes, 30029, France

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Toulouse, 31403, France

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Bari, 70124, Italy

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Catania, 95124, Italy

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Gallarate (VA), 21013, Italy

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Modena, 41100, Italy

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Padua, 35128, Italy

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Roma, 00100, Italy

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Siena, 53100, Italy

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Torino, 10126, 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, 656099, Russia

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Moscow, 105425, Russia

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Moscow, 117036, Russia

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Moscow, 121552, Russia

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Moscow, 123448, Russia

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Moscow, 125101, Russia

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Moscow, 125206, Russia

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Moscow, 127411, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Novosibirsk, 630003, Russia

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Novosibirsk, 630087, Russia

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Rostov-on-Don, 344068, Russia

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Saint Petersburg, 193318, Russia

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Saint Petersburg, 197089, Russia

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Saint Petersburg, Russia

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Yekaterinburg, Russia

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San Juan, Alicante, 03550, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Barcelona, 08036, Spain

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Madrid, 28007, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Valencia, 46009, Spain

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Valencia, 46010, Spain

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Zaragoza, 50009, Spain

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Karlshamn, 374 35, Sweden

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Malmo, 205 02, Sweden

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Skövde, 541 30, Sweden

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Stockholm, 171 76, Sweden

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Värnamo, 331 85, Sweden

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Västervik, 593 81, Sweden

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Bodelwyddan, Denbighshire, LL18 5UJ, United Kingdom

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South Yorkshire, DN1 2ET, United Kingdom

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Belmont, Durham, DH1 2QP, United Kingdom

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Blackpool, Lancashire, FY4 3AD, United Kingdom

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Urmston, Manchester, M41 0UH, United Kingdom

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Ashford, Middlesex, TW15 3EA, United Kingdom

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Nr Lichfield, Staffordshire, WS14 9JL, United Kingdom

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Pfizer Investigational Site

Addlestone, Surrey, KT15 2BH, United Kingdom

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Pfizer Investigational Site

Taunton, TA1 5DA, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: May 1, 2003
• Study Completion: May 1, 2004
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

RU (17); SE (6); FI (3); ES (9); IT (8); FR (8); PL (6); GB (9)