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

NCT00468650 | Completed Phase 4 Results

• 1 other identifier: A1481251
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)

  IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 \& 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.

  Week 6 LOCF

Secondary Outcomes (40)

• International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6

  Week 2, Week 4 and Week 6

• International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2

  Week 4 and Week 6

• International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline

  Week 2, Week 4 and Week 6

• International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2

  Week 4 and Week 6

• International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline

  Week 2, Week 4 and Week 6

Study Arms (1)

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

Interventions

sildenafil citrate DRUG

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.

Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

Pfizer Investigational Site

México, D.F., 11520, Mexico

Location

Pfizer Investigational Site

México, D.F., 11850, Mexico

Location

Pfizer Investigational Site

Naucalpan, Edo. de México, 53100, Mexico

Location

Pfizer Investigational Site

Zapopan, Jalisco, 45040, Mexico

Location

Pfizer Investigational Site

Zapopan, Jalisco, 45200, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico City, 11850, Mexico

Location

Pfizer Investigational Site

Aguascalientes, 20000, Mexico

Location

Pfizer Investigational Site

Durango, 34300, Mexico

Location

Pfizer Investigational Site

Naucalpan Edo. de Mexico, Mexico

Location

Related Links

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

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2007
• First Posted: May 3, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 18, 2021
• Results First Posted: March 16, 2009

Record last verified: 2021-01

Locations

ME (9)