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

NCT00343200 | Completed Phase 4

• 1 other identifier: A1481247
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 48

Brief Summary

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.

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

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

  Week 8

Secondary Outcomes (2)

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

  Weeks 8 and 12

• Safety and Tolerability

  up to 12 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Sildenafil

EXPERIMENTAL

Drug: Viagra (sildenafil citrate)

Interventions

Placebo DRUG

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.

Placebo

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).

Sildenafil

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (48)

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

Location

Pfizer Investigational Site

Mesa, Arizona, 85213, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85051, United States

Location

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

Beverly Hills, California, 90211, United States

Location

Pfizer Investigational Site

Huntington Beach, California, 92648, United States

Location

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

Santa Rosa, California, 95405, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80012, United States

Location

Pfizer Investigational Site

Colorado Springs, Colorado, 80904, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80212, United States

Location

Pfizer Investigational Site

Avon, Connecticut, 06001, United States

Location

Pfizer Investigational Site

Manchester, Connecticut, 06040, United States

Location

Pfizer Investigational Site

Wilmington, Delaware, 19801, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20010, United States

Location

Pfizer Investigational Site

Hollywood, Florida, 33021, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

Location

Pfizer Investigational Site

Ocala, Florida, 34474, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33607, United States

Location

Pfizer Investigational Site

Peoria, Illinois, 61602, United States

Location

Pfizer Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

Pfizer Investigational Site

Arkansas City, Kansas, 67005, United States

Location

Pfizer Investigational Site

Newton, Kansas, 67114, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66215, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67205, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67207, United States

Location

Pfizer Investigational Site

Livonia, Michigan, 48152, United States

Location

Pfizer Investigational Site

Edina, Minnesota, 55435, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89146, United States

Location

Pfizer Investigational Site

Binghamton, New York, 13901, United States

Location

Pfizer Investigational Site

Endwell, New York, 13760, United States

Location

Pfizer Investigational Site

New York, New York, 10016, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45236, United States

Location

Pfizer Investigational Site

Mogadore, Ohio, 44260, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73116, United States

Location

Pfizer Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

Pfizer Investigational Site

Greer, South Carolina, 29651, United States

Location

Pfizer Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84109, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84121, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23294, United States

Location

Pfizer Investigational Site

Spokane, Washington, 99207, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98405, United States

Location

Pfizer Investigational Site

Oregon, Wisconsin, 53575, United States

Location

Related Publications (3)

• Cappelleri JC, Chambers R. Addressing Bias in Responder Analysis of Patient-Reported Outcomes. Ther Innov Regul Sci. 2021 Sep;55(5):989-1000. doi: 10.1007/s43441-021-00298-5. Epub 2021 May 27.

  PMID: 34046875 DERIVED

• Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.

  PMID: 28892218 DERIVED

• Shabsigh R, Kaufman J, Magee M, Creanga D, Russell D, Budhwani M. Lack of awareness of erectile dysfunction in many men with risk factors for erectile dysfunction. BMC Urol. 2010 Nov 5;10:18. doi: 10.1186/1471-2490-10-18.

  PMID: 21054874 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2006
• First Posted: June 22, 2006
• Study Start: July 1, 2006
• Study Completion: September 1, 2007
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (48)