Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire
NCT00147628
Last updated date
ABOUT THIS STUDY
To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction
in men with ED as well as to validate the new Sexual Experience Questionnaire which
incorporates functional and emotional elements of a man's sexual experience into one
comprehensive questionnaire.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impotence
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Subjects who have been treated with more than 6 doses of sildenafil or any other
phosphodiesterase type 5 inhibitor
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire | |||
| Official Title ICMJE | A Multi-Center, Double-Blind Placebo Controlled, Flexible-Dose Study With An Open-Label Phase To Assess The Efficacy Of Sildenafil Citrate On Erectile Function And Intercourse Satisfaction As Well As To Validate The Sexual Experience Questionnaire And Its Treatment Responsiveness In Men With Erectile Dysfunction | |||
| Brief Summary | To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Impotence | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE | Not Provided | |||
| Publications * |
| |||
* 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 | |||
| Actual Enrollment ICMJE | 209 | |||
| Original Enrollment ICMJE | 180 | |||
| Actual Study Completion Date ICMJE | September 2006 | |||
| 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 | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00147628 | |||
| Other Study ID Numbers ICMJE | A1481236 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||