Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: August 31, 2005
Last updated: June 7, 2012
Last verified: June 2012

Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction

Condition Intervention Phase
Drug: Viagra (Sildenafil Citrate) 100 mg
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: Multicenter Randomized Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose - II

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.

Secondary Outcome Measures:
  • Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.

Estimated Enrollment: 250
Study Start Date: August 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men 18-70 years of age
  • Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.

Exclusion Criteria:

  • Subjects with penile implants
  • Subjects with a known history of retinitis pigmentosa.
  • Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
  Contacts and Locations
Please refer to this study by its identifier: NCT00143260

  Show 25 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00143260     History of Changes
Other Study ID Numbers: A1481240
Study First Received: August 31, 2005
Last Updated: June 7, 2012
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
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 15, 2014