A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.371 enrolled

Overview

To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

371

Conditions

Impotence

Interventions

PlaceboDRUG

Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.

Viagra (sildenafil citrate)DRUG

Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).

Eligibility

Sex: MALEMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men who do not identify as having ED with documented ED * Men 30 years of age and older * At least one prespecified risk factor for ED Exclusion Criteria: * Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis * Subjects with a known history of retinitis pigmentosa.

Locations (48)

Outcomes

Primary Outcomes

To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF).

Time frame: Week 8

Secondary Outcomes

Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance.

Time frame: Weeks 8 and 12

Safety and Tolerability

Time frame: up to 12 Weeks

Data from ClinicalTrials.gov

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

Pfizer Investigational Site

Huntsville, Alabama, United States

Pfizer Investigational Site

Mesa, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Anaheim, California, United States

Pfizer Investigational Site

Beverly Hills, California, United States

Pfizer Investigational Site

Huntington Beach, California, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Santa Rosa, California, United States

Pfizer Investigational Site

Aurora, Colorado, United States

...and 38 more locations