Mild To Moderate Erectile Dysfunction Study

NCT00137072

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, , United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impotence
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men 18-70 years of age

- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Mild To Moderate Erectile Dysfunction Study
Official Title  ICMJE 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
Brief Summary Safety/Efficacy of 100-mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Impotence
Intervention  ICMJE Drug: Viagra (Sildenafil Citrate) 100 mg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2011)
355
Original Enrollment  ICMJE
 (submitted: August 26, 2005)
350
Actual Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137072
Other Study ID Numbers  ICMJE A1481230
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP