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OpenTrials
Completed

NCT Number: NCT00343200

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

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.

Completed

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

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

    Time frame: Week 8

Secondary outcomes

  1. 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

  2. Safety and Tolerability

    Time frame: up to 12 Weeks

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Study completion
2007
First posted
Jun 22, 2006
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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