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NCT00343200 Clinical Trial

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

Impotence Clinical Trial

Official title:
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00343200
Other study ID # A1481247
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2006
Est. completion date September 2007

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 371
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 30 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
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)
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).

Locations
Country Name City State
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Arkansas City Kansas
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Avon Connecticut
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Binghamton New York
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Edina Minnesota
United States Pfizer Investigational Site Endwell New York
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Huntington Beach California
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Livonia Michigan
United States Pfizer Investigational Site Manchester Connecticut
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Mogadore Ohio
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newton Kansas
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oregon Wisconsin
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Peoria Illinois
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Santa Rosa California
United States Pfizer Investigational Site Simpsonville South Carolina
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Wilmington Delaware

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). Week 8
Secondary 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
Secondary Safety and Tolerability up to 12 Weeks
See also
  Status Clinical Trial Phase
Completed NCT00159848 - Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra Phase 4
Completed NCT00654082 - A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction Phase 4
Completed NCT00882934 - The Management of Erectile Dysfunction With Placebo Only N/A
Withdrawn NCT00382161 - Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors Phase 3
Recruiting NCT00297544 - Effect of Sildenafil on Endothelial Function N/A
Completed NCT00249730 - Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function. Phase 4
Completed NCT00245596 - Evaluation of the Index of Sexual Life Questionnaire Phase 4
Completed NCT00422578 - Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction Phase 4
Completed NCT00547183 - Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection Phase 3
Completed NCT00547092 - Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection Phase 4
Completed NCT00547508 - To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking Phase 3
Completed NCT00422734 - Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life Phase 3
Completed NCT00301262 - Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied Phase 4
Completed NCT00245258 - Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction Phase 4
Completed NCT00147628 - Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire Phase 4
Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
Completed NCT03830164 - Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer Phase 2
Recruiting NCT00498680 - Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Phase 4
Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
Completed NCT00143221 - Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH) Phase 4

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