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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mexico, D.f., 11520 Mexico
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subject with resting sitting hypotension (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.

NCT00468650
Pfizer
Completed
A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.

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A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Erectile Dysfunction
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.
Active Comparator: Open label
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.
Intervention: Drug: sildenafil citrate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00468650
A1481251
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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