Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.350 enrolled

Overview

The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

350

Conditions

Impotence

Interventions

ViagraDRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * clinical diagnosis of erectile dysfunction (ED) * lower urinary tract symptoms (LUTS) Exclusion Criteria: * previous prostate surgery or invasive intervention for BPH * active urinary tract disease

Outcomes

Primary Outcomes

Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo

Secondary Outcomes

Effect on: IPSS Effect on IPSS QoL Orgasmic Function

Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry

Event Log Variables

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.