Mild To Moderate Erectile Dysfunction Study
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137072
First received: August 26, 2005
Last updated: September 3, 2011
Last verified: September 2011
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Purpose
Safety/Efficacy of 100-mg 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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 Outcome Measures:
- To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 12 hrs after a dose of Viagra. Other questionnaires such as SEP, IIEF.
| Enrollment: | 355 |
| Study Start Date: | April 2005 |
| Study Completion Date: | February 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137072
Show 33 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137072
Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00137072 History of Changes |
| Other Study ID Numbers: | A1481230 |
| Study First Received: | August 26, 2005 |
| Last Updated: | September 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Erectile Dysfunction Genital Diseases, Male Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders Sildenafil Cardiovascular Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Therapeutic Uses Urological Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on February 25, 2015