Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00245258
• Collaborator: (none)
• Enrollment: 312
• Locations: 19
• Duration (Months): 10
• Patients Per Site: 16.4
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The study objective is to:

1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end of the double-blind phase

2. To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX_Q).

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind Placebo Controlled, Fixed Dose Study With An Open-Label, Flexible Dose Phase To Assess The Efficacy Of Sildenafil Citrate In Providing A Better Sexual Experience Including Quality Of Erections And Satisfaction In Men With Erectile Dysfunction
• Study Start Date: Nov 1, 2005
• Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score. []

Secondary Outcome Measures

1. The change from baseline to visit 6 (wk 12) in the IIEF-EF domain; the change from baseline to visit 4 (wk 8) and visit 6 (wk 12) in the domains and total score as well as the individual questions of the sexual experience questionnaire []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male subjects aged 18-65.

• Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion Criteria:

• Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening].

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Pusan		Korea, Republic of	602-739
2	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
3	Pfizer Investigational Site	Seoul		Korea, Republic of	135-710
4	Pfizer Investigational Site	Seoul		Korea, Republic of	136-705
5	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
6	Pfizer Investigational Site	Seoul		Korea, Republic of	158-710
7	Pfizer Investigational Site	Moscow		Russian Federation	105425
8	Pfizer Investigational Site	Moscow		Russian Federation	117036
9	Pfizer Investigational Site	Moscow		Russian Federation	125101
10	Pfizer Investigational Site	Rostov-on-Don		Russian Federation	344022
11	Pfizer Investigational Site	St. Petersburg		Russian Federation
12	Pfizer Investigational Site	Santander	Cantabria	Spain	39008
13	Pfizer Investigational Site	Barcelona		Spain	08035
14	Pfizer Investigational Site	Madrid		Spain	28046
15	Pfizer Investigational Site	Sevilla		Spain	41014
16	Pfizer Investigational Site	Karlshamn		Sweden	374 35
17	Pfizer Investigational Site	Malmo		Sweden	205 02
18	Pfizer Investigational Site	Skovde		Sweden	541 31
19	Pfizer Investigational Site	Stockholm		Sweden	171 76

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: NCT00245258
• Other Study ID Numbers: A1481239
• First Posted: Oct 27, 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