Quality of Erection Study

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.300 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Erectile Dysfunction

Interventions

Sildenafil CitrateDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\]

Locations (23)

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Outcomes

Primary Outcomes

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

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)

Data from ClinicalTrials.gov

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