Mild To Moderate Erectile Dysfunction Study

• ClinicalTrials.gov Identifier: NCT00137072
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Last Update Posted: February 1, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: August 26, 2005
• First Posted Date: August 29, 2005
• Last Update Posted Date: February 1, 2021
• Study Start Date: April 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: August 26, 2005): To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 15, 2007): 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.
• Original Secondary Outcome Measures (submitted: August 26, 2005): Secondarily to determine the proportion of sexual intercourses that are successful 12 hours after dosing. Additionally, to determine the proportion of men with mild to moderate ED who can successfully have and keep an erection sufficient for successful
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mild To Moderate Erectile Dysfunction Study
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Impotence
• Intervention: Drug: Viagra (Sildenafil Citrate) 100 mg
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 26, 2011): 355
• Original Enrollment (submitted: August 26, 2005): 350
• Actual Study Completion Date: February 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00137072
• Other Study ID Numbers: A1481230
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2021