A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00468650

Purpose

A multicenter open label study to assess the efficacy of sildenafil rapid dose titration to 100 mg in men with erectile dysfunction, based on the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: sildenafil citrate	Phase IV

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate Amphetamine Methamphetamine BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Multicenter, Open Label, High Dose (100mg) Rapid Titration Study, To Evaluate The Efficacy And Satisfaction Of Patrex® (Sildenafil Citrate) In Men With Erectile Dysfunction In Mexico.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline (Week 0) in the International Index of Erectile Function (IIEF), Erectile Function (EF) domain score at the end of 100 mg period (Week 6). [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline (Week 0) at each time point (Weeks 2, 4 and 6), as well as the change from the end of the 50-mg period (Week 2) at each subsequent time point (Weeks 4 and 6) in the following assessments. [ Time Frame: Week 0, Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
International Index of erectile Function (IIEF) questionnaire: individual questions and the following additional domain scores: Orgasmic Function domain, Sexual Desire domain, Intercourse Satisfaction domain, Overall Satisfaction domain. [ Time Frame: Week 0, Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
Quality of Erection Questionnaire (QEQ): individual QEQ questions the QEQ total score. [ Time Frame: Week 0, Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
Sexual Experience Questionnaire (Sex-Q): Erection, Satisfaction, and Relationship domains. [ Time Frame: Week 0, Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
Intercourse success rate variables based on the Event Log/Sexual Encounter Profile (SEP)/Erection Hardness Grading Scale (EHGS). [ Time Frame: Week 0, Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]
Safety and tolerability based on adverse events, discontinuations, and changes in vital signs. [ Time Frame: Week 0, Week 2, Week 4 and Week 6 ] [ Designated as safety issue: No ]

Enrollment:	117
Study Start Date:	June 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open label: Active Comparator Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive Patrex® 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to Patrex® 100 mg PRN for the following four weeks.	Drug: sildenafil citrate Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.

Arms

Assigned Interventions

Open label: Active Comparator

Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive Patrex® 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to Patrex® 100 mg PRN for the following four weeks.

Drug: sildenafil citrate

Tablets, 50mg and 100mg , Medication will be taken orally with a glass of water approximately one hour (30 min to 4 hours) before sexual activity. Subjects are to take one dose in any calendar day.Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil 100 mg PRN for the following four weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented Clinical diagnosis of Erectile Dysfunction (ED) by International Index of Erectile Function (IIEF) Erectile Function (EF) Domain score less than or equal to 25.
Subjects must be in a stable relationship

Exclusion Criteria:

Subject with resting sitting hypotension (BP <90/50 mmHg) or hypertension (BP>170/110 mmHg) and orthostatic hypotension.
Subjects receiving any PDE (Phosphodiesterase)-5 inhibitors within 4 weeks prior to the date of screening.
Subjects with severe hepatic impairment, a known history of retinitis pigmentare.
Subjects with significant cardiovascular disease in the last 3 months (per medical history.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468650

Locations

Mexico
Pfizer Investigational Site
Naucalpan Edo. de Mexico, Mexico
Pfizer Investigational Site
Aguascalientes, Mexico, 20000
Pfizer Investigational Site
Durango, Mexico, 34300
Mexico, D.F.
Pfizer Investigational Site
Mexico, D.F., Mexico, 11520
Pfizer Investigational Site
Mexico, D.F., Mexico, 11850
Mexico, DF
Pfizer Investigational Site
Mexico, DF, Mexico, 11850
Mexico, Distrito Federal
Pfizer Investigational Site
Mexico, Distrito Federal, Mexico, 11850
Mexico, Edo. de México
Pfizer Investigational Site
Naucalpan, Edo. de México, Mexico, 53100
Mexico, Jalisco
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45040
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45200

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481251
Study First Received:	May 1, 2007
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00468650
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Methamphetamine
Sexual Dysfunction, Physiological
Mental Disorders
Citric Acid

Amphetamine
Sildenafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Agents
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009