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

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

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).

Study Overview

• Status: Completed
• Conditions: Impotence
• Intervention / Treatment: Drug: Sildenafil Citrate

• Study Type: Interventional
• Enrollment: 312
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of, 602-739
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 136-705
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 158-710
    • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 105425
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 117036
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 125101
    • Pfizer Investigational Site
  • Rostov-on-Don, Russian Federation, 344022
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation
    • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • Pfizer Investigational Site
  • Madrid, Spain, 28046
    • Pfizer Investigational Site
  • Sevilla, Spain, 41014
    • Pfizer Investigational Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Pfizer Investigational Site
• Sweden
  • Karlshamn, Sweden, 374 35
    • Pfizer Investigational Site
  • Malmo, Sweden, 205 02
    • Pfizer Investigational Site
  • Skovde, Sweden, 541 31
    • Pfizer Investigational Site
  • Stockholm, Sweden, 171 76
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Cappelleri JC, Tseng LJ, Stecher V, Goldstein I. Enriching the Interpretation of the Erectile Dysfunction Inventory of Treatment Satisfaction: Characterizing Success in Treatment Satisfaction. J Sex Med. 2018 May;15(5):732-740. doi: 10.1016/j.jsxm.2018.03.078.
• Kirby M, Creanga DL, Stecher VJ. Erectile function, erection hardness and tolerability in men treated with sildenafil 100 mg vs. 50 mg for erectile dysfunction. Int J Clin Pract. 2013 Oct;67(10):1034-9. doi: 10.1111/ijcp.12229.
• Claes HIM, Goldstein I, Althof SE, Berner MM, Cappelleri JC, Bushmakin AG, Symonds T, Schnetzler G. Understanding the effects of sildenafil treatment on erection maintenance and erection hardness. J Sex Med. 2010 Jun;7(6):2184-2191. doi: 10.1111/j.1743-6109.2010.01791.x. Epub 2010 Apr 1.
• Loran OB, Stroberg P, Lee SW, Park NC, Kim SW, Tseng LJ, Collins S, Stecher VJ. Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt. J Sex Med. 2009 Oct;6(10):2826-35. doi: 10.1111/j.1743-6109.2009.01428.x.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Study Completion: September 1, 2006

Study Registration Dates

• First Submitted: October 25, 2005
• First Submitted That Met QC Criteria: October 25, 2005
• First Posted (Estimate): October 27, 2005

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A1481239