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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.780 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

780

Conditions

Erectile Dysfunction

Interventions

sildenafilDRUG

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.

placeboDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (66)

Outcomes

Primary Outcomes

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

Time frame: Week 12

Secondary Outcomes

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

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

Time frame: Week 12

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

Time frame: 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)

Time frame: Week 12

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

Time frame: Week 12

Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity

Time frame: Week 12

Changes of the SEAR questions overall and by type of co-morbidity

Time frame: Week 12

Changes of the IIEF questions overall and by type of co-morbidity

Time frame: Week 12

Changes of the IIEF domains overall and by type of co-morbidity

Data from ClinicalTrials.gov

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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

...and 56 more locations