Not Signed In -
Impotence |
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Clinical Trial: An Assessment Of Efficacy, Safety & Toleration Of An Investigational New Drug In Patients With Erectile Dysfunction
This study is not yet open for patient recruitment.
Verified by Pfizer January 2006
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Purpose
The primary aim of this study is to assess how effective an investigational new drug is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of the investigational new drug, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).
| Condition | Intervention | Phase |
|---|---|---|
| Impotence | Drug: Investigational new drug Drug: Sildenafil 100mg | Phase II |
MedlinePlus related topics: Erectile Dysfunction
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of An Investigational New Drug On Erectile Function, Using 100mg Sildenafil As A Positive Control
Further study details as provided by Pfizer:
Primary Outcomes: Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Secondary Outcomes: Duration and quality of penile erections recorded in a self-assessment diary.
Expected Total Enrollment: 32
Secondary Outcomes: Duration and quality of penile erections recorded in a self-assessment diary.
Expected Total Enrollment: 32
Study start: January 2006
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
Exclusion Criteria:
- Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
- Patients on nitrates or alpha-blocker medications.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00273416
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A7771002
Last Updated: January 6, 2006
Record first received: January 4, 2006
ClinicalTrials.gov Identifier: NCT00273416
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: January 6, 2006
Record first received: January 4, 2006
ClinicalTrials.gov Identifier: NCT00273416
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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