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Completed

NCT Number: NCT00648596

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Oulu, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

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

    Time frame: Week 12

Secondary outcomes

  1. 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

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

    Time frame: Week 12

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

    Time frame: Week 12

  4. 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

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

  10. Degrees of severity in the IIEF erectile function

    Time frame: Week 12

  11. 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

    Time frame: Week 12

  12. Changes in the questions from the event log overall and by type of co-morbidity

    Time frame: Week 12

  13. 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

    Time frame: Week 12

  14. Differences in the intercourse success rates derived from the event log overall and by type of comorbidity

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Apr 1, 2008
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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