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Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159809
First received: September 8, 2005
Last updated: January 18, 2008
Last verified: January 2008
History of Changes
  Purpose

This study will measure the impact of treatment with Viagra on the depressive symptoms and quality of life in men with erectile dysfunction who have untreated depressive symptoms meeting the DSM-IV criteria for dysthymia or depression not otherwise specified (NOS), including minor depressive symptoms but excluding any form of psychotic disorder.


Condition Intervention Phase
Impotence
Depression
 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
Primary Purpose: Treatment
Official Title: A Multi-Center, Flexible Dose Study With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Evaluate The Impact Of Treatment With Sildenafil Citrate On The Symptoms Of Depression And Quality Of Life (Qol) Of Male Patients With Erectile Dysfunction (ED)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Describe the effect of treatment with sildenafil on the depressive symptoms in subjects with ED as measured by the BDI II at the end of the double-blind phase

Secondary Outcome Measures:
  • Measure QoL improvement; Describe treatment effect on social motivation & behavior; Describe relationship between depression severity and ED; Describe effectiveness of sildenafil; Describe correlation between the SEX FX and the IIEF; Validate the PREFA

Estimated Enrollment: 140
Study Start Date: March 2004
Estimated Study Completion Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men above age of majority with ED (SHIM score less than 21)
  • Beck Depression Inventory II score between 14 and 28

Exclusion Criteria:

  • Subjects with symptoms of mania or major depressive disorders as demonstrated by the Mini International Neuropsychiatric Interview (MINI)
  • Subjects who require treatment with antipsychotics, mood stabilizers, antidepressant agents or lithium (concomitant use of benzodiazepines is allowed) or who has required treatment with any of the above medication within the past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159809

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

No publications provided

ClinicalTrials.gov Identifier: NCT00159809     History of Changes
Other Study ID Numbers: A1481110
Study First Received: September 8, 2005
Last Updated: January 18, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Depression
Depressive Disorder
Erectile Dysfunction
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender 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 May 22, 2013