Mild To Moderate Erectile Dysfunction Study

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00137072
• Collaborator: (none)
• Enrollment: 355
• Locations: 33
• Duration (Months): 10.1
• Patients Per Site: 10.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Impotence	Drug: Viagra (Sildenafil Citrate) 100 mg	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 355 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• 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
• Study Start Date: Apr 1, 2005
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States
2	Pfizer Investigational Site	Homewood	Alabama	United States
3	Pfizer Investigational Site	Hoover	Alabama	United States
4	Pfizer Investigational Site	Huntsville	Alabama	United States
5	Pfizer Investigational Site	Phoenix	Arizona	United States
6	Pfizer Investigational Site	Beverly Hills	California	United States
7	Pfizer Investigational Site	La Mesa	California	United States
8	Pfizer Investigational Site	Newport Beach	California	United States
9	Pfizer Investigational Site	San Diego	California	United States
10	Pfizer Investigational Site	Aurora	Colorado	United States
11	Pfizer Investigational Site	Middlebury	Connecticut	United States
12	Pfizer Investigational Site	Waterbury	Connecticut	United States
13	Pfizer Investigational Site	Gainesville	Florida	United States
14	Pfizer Investigational Site	New Port Richey	Florida	United States
15	Pfizer Investigational Site	South Miami	Florida	United States
16	Pfizer Investigational Site	Tallahassee	Florida	United States
17	Pfizer Investigational Site	Tampa	Florida	United States
18	Pfizer Investigational Site	Fort Wayne	Indiana	United States
19	Pfizer Investigational Site	Jeffersonville	Indiana	United States
20	Pfizer Investigational Site	Des Moines	Iowa	United States
21	Pfizer Investigational Site	New Orleans	Louisiana	United States
22	Pfizer Investigational Site	Shreveport	Louisiana	United States
23	Pfizer Investigational Site	Hattiesburg	Mississippi	United States
24	Pfizer Investigational Site	Las Vegas	Nevada	United States
25	Pfizer Investigational Site	Bay Shore	New York	United States
26	Pfizer Investigational Site	Kingston	New York	United States
27	Pfizer Investigational Site	New York	New York	United States
28	Pfizer Investigational Site	Poughkeepsie	New York	United States
29	Pfizer Investigational Site	Cincinnati	Ohio	United States
30	Pfizer Investigational Site	Nashville	Tennessee	United States
31	Pfizer Investigational Site	San Antonio	Texas	United States
32	Pfizer Investigational Site	Lacey	Washington	United States
33	Pfizer Investigational Site	Spokane	Washington	United States

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00137072
• Other Study ID Numbers: A1481230
• First Posted: Aug 29, 2005
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Erectile Dysfunction; Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021