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OpenTrials
Completed

NCT Number: NCT00159900

Quality of Erection Study

The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).

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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–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Belo Horizonte, Minas Gerais, Brazil

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male subjects aged 18-55
  • Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion criteria

  • Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening]

Treatment and study plan

sildenafil citrate

Drug

Primary outcomes

  1. Responses to Question 5 (erectile hardness) of the Event Log as measured from baseline to the end of double-blind treatment (week 6).

Secondary outcomes

  1. Responses to the Quality of Erectile Questionnaire (QEQ) Responses to International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Multicenter, Parallel Group Flexible Dose Study With A Double Blind, Randomized, Placebo Controlled Phase And An Open-Label Phase To Evaluate The Quality Of Erections In Men With Erectile Dysfunction Treated With Sildenafil Citrate

Important dates

Study start
2005
Study completion
2006
First posted
Sep 12, 2005
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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