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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00343200
First received: June 20, 2006
Last updated: September 9, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Impotence
Drug: Placebo
Drug: Viagra (sildenafil citrate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: up to 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 371
Study Start Date: July 2006
Study Completion Date: September 2007
Arms Assigned Interventions
Placebo Comparator: Placebo 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.
Experimental: Sildenafil
Not Specified
Drug: 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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343200

  Show 48 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00343200     History of Changes
Other Study ID Numbers: A1481247
Study First Received: June 20, 2006
Last Updated: September 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014