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

NCT ID: NCT00245258

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Impotence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sildenafil Citrate

Intervention Type DRUG

Eligibility Criteria

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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 \[Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening\].
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Rostov-on-Don, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Pusan, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Santander, Cantabria, Spain

Site Status

Pfizer Investigational Site

Barcelona, , Spain

Site Status

Pfizer Investigational Site

Madrid, , Spain

Site Status

Pfizer Investigational Site

Seville, , Spain

Site Status

Pfizer Investigational Site

Karlshamn, , Sweden

Site Status

Pfizer Investigational Site

Malmo, , Sweden

Site Status

Pfizer Investigational Site

Skövde, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Countries

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Russia South Korea Spain Sweden

References

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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.

Reference Type DERIVED
PMID: 29699758 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24073975 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20384942 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19817982 (View on PubMed)

Related Links

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Other Identifiers

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A1481239

Identifier Type: -

Identifier Source: org_study_id

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