Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00249730
• Collaborator: (none)
• Enrollment: 510
• Locations: 39
• Patients Per Site: 13.1

Study Details

Study Description

Brief Summary

To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.

Condition or Disease	Intervention/Treatment	Phase
Impotence	Drug: Sildenafil	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction
• Study Start Date: Oct 1, 2005

Outcome Measures

Primary Outcome Measures

1. Change in IIEF erectile function domain score at the end of double blind treatment. []

Secondary Outcome Measures

1. Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.

• Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.

Exclusion Criteria:

• Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.

• Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Kitchener	Ontario	Canada
2	Pfizer Investigational Site	Sarnia	Ontario	Canada
3	Pfizer Investigational Site	Toronto	Ontario	Canada
4	Pfizer Investigational Site	St. Leonard	Quebec	Canada
5	Pfizer Investigational Site	Trois-Rivieres	Quebec	Canada
6	Pfizer Investigational Site	Lille		France
7	Pfizer Investigational Site	LYON Cedex 03		France
8	Pfizer Investigational Site	Montpellier		France
9	Pfizer Investigational Site	PARIS cedex 18		France
10	Pfizer Investigational Site	Goudi	Athens	Greece
11	Pfizer Investigational Site	Patras		Greece
12	Pfizer Investigational Site	Thessaloniki		Greece
13	Pfizer Investigational Site	Beer Sheba		Israel
14	Pfizer Investigational Site	Haifa		Israel
15	Pfizer Investigational Site	Petach Tikva		Israel
16	Pfizer Investigational Site	Tel- Aviv		Israel
17	Pfizer Investigational Site	Bologna		Italy
18	Pfizer Investigational Site	Firenze		Italy
19	Pfizer Investigational Site	L'Aquila		Italy
20	Pfizer Investigational Site	Milano		Italy
21	Pfizer Investigational Site	Roma		Italy
22	Pfizer Investigational Site	Moscow		Russian Federation
23	Pfizer Investigational Site	La Laguna	Santa Cruz De Tenerife	Spain
24	Pfizer Investigational Site	Alicante		Spain
25	Pfizer Investigational Site	Barcelona		Spain
26	Pfizer Investigational Site	Madrid		Spain
27	Pfizer Investigational Site	Malaga		Spain
28	Pfizer Investigational Site	Sevilla		Spain
29	Pfizer Investigational Site	Valencia		Spain
30	Pfizer Investigational Site	Belmont	Durham	United Kingdom
31	Pfizer Investigational Site	Ashford	Middlesex	United Kingdom
32	Pfizer Investigational Site	Weybridge	Surrey	United Kingdom
33	Pfizer Investigational Site	Chippenham	Wilts.	United Kingdom
34	Pfizer Investigational Site	Trowbridge	Wiltshire	United Kingdom
35	Pfizer Investigational Site	Bath		United Kingdom
36	Pfizer Investigational Site	Coventry		United Kingdom
37	Pfizer Investigational Site	Doncaster		United Kingdom
38	Pfizer Investigational Site	Dundee		United Kingdom
39	Pfizer Investigational Site	Glasgow		United Kingdom

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: NCT00249730
• Other Study ID Numbers: A1481237
• First Posted: Nov 7, 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