CClinicalTrials.gg
CompletedNCT00137072Updated Feb 1, 2021

Mild To Moderate Erectile Dysfunction Study

A Phase 4 interventional study of Viagra (Sildenafil Citrate) 100 mg in Impotence, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 33 sites in United States. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
355
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Impotence

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03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 355 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
355 participants (actual)

Interventions

  • DrugViagra (Sildenafil Citrate) 100 mg
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 12 hrs after a dose of Viagra. Other questionnaires such as SEP, IIEF.

07

Study locations

33 sites
  • Pfizer Investigational Site
    Birmingham, Alabama, United States
  • Pfizer Investigational Site
    Homewood, Alabama, United States
  • Pfizer Investigational Site
    Hoover, Alabama, United States
  • Pfizer Investigational Site
    Huntsville, Alabama, United States
  • Pfizer Investigational Site
    Phoenix, Arizona, United States
  • Pfizer Investigational Site
    Beverly Hills, California, United States
  • Pfizer Investigational Site
    La Mesa, California, United States
  • Pfizer Investigational Site
    Newport Beach, California, United States
  • Pfizer Investigational Site
    San Diego, California, United States
  • Pfizer Investigational Site
    Aurora, Colorado, United States
  • Pfizer Investigational Site
    Middlebury, Connecticut, United States
  • Pfizer Investigational Site
    Waterbury, Connecticut, United States
  • Pfizer Investigational Site
    Gainesville, Florida, United States
  • Pfizer Investigational Site
    New Port Richey, Florida, United States
  • Pfizer Investigational Site
    South Miami, Florida, United States
  • Pfizer Investigational Site
    Tallahassee, Florida, United States
  • Pfizer Investigational Site
    Tampa, Florida, United States
  • Pfizer Investigational Site
    Fort Wayne, Indiana, United States
  • Pfizer Investigational Site
    Jeffersonville, Indiana, United States
  • Pfizer Investigational Site
    Des Moines, Iowa, United States
  • Pfizer Investigational Site
    New Orleans, Louisiana, United States
  • Pfizer Investigational Site
    Shreveport, Louisiana, United States
  • Pfizer Investigational Site
    Hattiesburg, Mississippi, United States
  • Pfizer Investigational Site
    Las Vegas, Nevada, United States
  • Pfizer Investigational Site
    Bay Shore, New York, United States
  • Pfizer Investigational Site
    Kingston, New York, United States
  • Pfizer Investigational Site
    New York, New York, United States
  • Pfizer Investigational Site
    Poughkeepsie, New York, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio, United States
  • Pfizer Investigational Site
    Nashville, Tennessee, United States
  • Pfizer Investigational Site
    San Antonio, Texas, United States
  • Pfizer Investigational Site
    Lacey, Washington, United States
  • Pfizer Investigational Site
    Spokane, Washington, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00137072
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Aug 29, 2005
Start date
Apr 2005
Completion
Feb 2006
Last update
Feb 1, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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