Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose
NCT00143260
ABOUT THIS STUDY
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- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose | |||
Official Title ICMJE | 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 | |||
Brief Summary | Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Impotence | |||
Intervention ICMJE | Drug: Viagra (Sildenafil Citrate) 100 mg | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 250 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2006 | |||
Actual Primary Completion Date | May 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00143260 | |||
Other Study ID Numbers ICMJE | A1481240 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |