Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
NCT00249730
ABOUT THIS STUDY
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- Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤ 25.
- Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
- Subjects in whom sexual activity is inadvisable in the opinion of the investigator
such as significant cardiovascular disease in the last 6 months; including cardiac
failure, myocardial infarction, unstable angina, stroke or transient ischemic attack
(TIA), symptomatic or clinically significant cardiac arrhythmias including atrial
fibrillation.
- Subjects who are currently taking or are likely to be treated with nitrates or nitric
oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as
aerosols) on either regular or intermittent basis.
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Descriptive Information | ||||
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Brief Title ICMJE | Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function. | |||
Official Title ICMJE | A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction | |||
Brief Summary | To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg. | |||
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: Sildenafil | |||
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 | 510 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (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 | Canada, France, Greece, Israel, Italy, Russian Federation, Spain, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00249730 | |||
Other Study ID Numbers ICMJE | A1481237 | |||
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 |
| |||
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 |