A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00343200

Collaborator

(none)

371

Enrollment

Locations

Arms

Duration (Months)

7.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.

Condition or Disease	Intervention/Treatment	Phase
Impotence	Drug: Placebo Drug: Viagra (sildenafil citrate)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

371 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.

Study Start Date :

Jul 1, 2006

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
Experimental: Sildenafil	Drug: Viagra (sildenafil citrate) Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.

Experimental: Sildenafil

Drug: Viagra (sildenafil citrate)

Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).

Outcome Measures

Primary Outcome Measures

To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). [Week 8]

Secondary Outcome Measures

Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance. [Weeks 8 and 12]
Safety and Tolerability [up to 12 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Men who do not identify as having ED with documented ED
Men 30 years of age and older
At least one prespecified risk factor for ED

Exclusion Criteria:

Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
Subjects with a known history of retinitis pigmentosa.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Huntsville	Alabama	United States	35801
2	Pfizer Investigational Site	Mesa	Arizona	United States	85213
3	Pfizer Investigational Site	Phoenix	Arizona	United States	85023
4	Pfizer Investigational Site	Phoenix	Arizona	United States	85051
5	Pfizer Investigational Site	Anaheim	California	United States	92801
6	Pfizer Investigational Site	Beverly Hills	California	United States	90211
7	Pfizer Investigational Site	Huntington Beach	California	United States	92648
8	Pfizer Investigational Site	San Diego	California	United States	92123
9	Pfizer Investigational Site	Santa Rosa	California	United States	95405
10	Pfizer Investigational Site	Aurora	Colorado	United States	80012
11	Pfizer Investigational Site	Colorado Springs	Colorado	United States	80904
12	Pfizer Investigational Site	Denver	Colorado	United States	80212
13	Pfizer Investigational Site	Avon	Connecticut	United States	06001
14	Pfizer Investigational Site	Manchester	Connecticut	United States	06040
15	Pfizer Investigational Site	Wilmington	Delaware	United States	19801
16	Pfizer Investigational Site	Washington	District of Columbia	United States	20010
17	Pfizer Investigational Site	Hollywood	Florida	United States	33021
18	Pfizer Investigational Site	Jacksonville	Florida	United States	32216
19	Pfizer Investigational Site	Ocala	Florida	United States	34474
20	Pfizer Investigational Site	Pembroke Pines	Florida	United States	33024
21	Pfizer Investigational Site	Tampa	Florida	United States	33607
22	Pfizer Investigational Site	Peoria	Illinois	United States	61602
23	Pfizer Investigational Site	Fort Wayne	Indiana	United States	46825
24	Pfizer Investigational Site	Arkansas City	Kansas	United States	67005
25	Pfizer Investigational Site	Newton	Kansas	United States	67114
26	Pfizer Investigational Site	Overland Park	Kansas	United States	66215
27	Pfizer Investigational Site	Wichita	Kansas	United States	67205
28	Pfizer Investigational Site	Wichita	Kansas	United States	67207
29	Pfizer Investigational Site	Livonia	Michigan	United States	48152
30	Pfizer Investigational Site	Edina	Minnesota	United States	55435
31	Pfizer Investigational Site	Las Vegas	Nevada	United States	89146
32	Pfizer Investigational Site	Binghamton	New York	United States	13901
33	Pfizer Investigational Site	Endwell	New York	United States	13760
34	Pfizer Investigational Site	New York	New York	United States	10016
35	Pfizer Investigational Site	Cincinnati	Ohio	United States	45236
36	Pfizer Investigational Site	Mogadore	Ohio	United States	44260
37	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73116
38	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74136
39	Pfizer Investigational Site	Greer	South Carolina	United States	29651
40	Pfizer Investigational Site	Simpsonville	South Carolina	United States	29681
41	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
42	Pfizer Investigational Site	San Antonio	Texas	United States	78229
43	Pfizer Investigational Site	Salt Lake City	Utah	United States	84109
44	Pfizer Investigational Site	Salt Lake City	Utah	United States	84121
45	Pfizer Investigational Site	Richmond	Virginia	United States	23294
46	Pfizer Investigational Site	Spokane	Washington	United States	99207
47	Pfizer Investigational Site	Tacoma	Washington	United States	98405
48	Pfizer Investigational Site	Oregon	Wisconsin	United States	53575

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:

NCT00343200

Other Study ID Numbers:

A1481247

First Posted:

Jun 22, 2006

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