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Sildenafil |
sildenafil citrate; Viagra |
Clinical Trial: Mild ED II
This study is not yet open for patient recruitment.
Verified by Pfizer August 2005
|
Purpose
Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
| Condition | Intervention | Phase |
|---|---|---|
| Impotence | Drug: Viagra (Sildenafil Citrate) 100 mg | Phase IV |
MedlinePlus related topics: Erectile Dysfunction
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Multicenter Randomized Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra® 8 Hours Post-Dose - II
Further Study Details:
Primary Outcomes: To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
Secondary Outcomes: proportion of patients at various endpoints
Expected Total Enrollment: 250
Secondary Outcomes: proportion of patients at various endpoints
Expected Total Enrollment: 250
Study start: August 2005
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration. Erectile dysfunction
Exclusion Criteria:
- Subjects with penile implants
- Subjects with a known history of retinitis pigmentosa.
- Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00143260
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1481240
Last Updated: September 1, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00143260
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: September 1, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00143260
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Resources
- Sildenafil (Drug Digest)
- Viagra (Drug Digest)
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