Trial record 19 of 61 for:
Open Studies | "Impotence"
Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by University Hospitals of Cleveland.
Recruitment status was Recruiting
Information provided by:
University Hospitals of Cleveland
First received: November 18, 2005
Last updated: November 26, 2007
Last verified: November 2005
Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.
Drug: Alfuzosin 10 mg
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective, Open Label, Study to Assess the Efficacy of Alfuzosin 10 mg Tablet Once a Day in Male Subjects Suffering From Benign Prostate Hypertrophy Associated Lower Urinary Tract Symptoms and Erectile Dysfunction
Primary Outcome Measures:
- Evaluate the medication on erection maintenance
Secondary Outcome Measures:
- Assess effect of Uroxatral on BPH and sexual function using questionnaires
| Estimated Enrollment:
| Study Start Date:
The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.
|Ages Eligible for Study:
||45 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Males 45-75 years of age
- Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED
- Men with steady partner and who agree to attempt sex once a week.
- Prostate cancer
- Penile disease
- Cardiac co-morbidity
- Pre-existing co-morbid conditions
- History of sensitivity to the drug or similar drugs
- Enrollment in another clinical trial
- Impaired hepatic function
- Impaired renal function
- Mental conditions rendering subject unable to understand the study
- Subjects not likely to comply with protocol
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: NCT00256399
|University Hospitals of Cleveland
|Cleveland, Ohio, United States, 44106 |
|Contact: Ann M Serenko, MS, RN 216-844-3515 firstname.lastname@example.org |
|Contact: Allen D Seftel, MD 216-844-7728 email@example.com |
|Principal Investigator: Allen D Seftel, MD |
|Sub-Investigator: Martin Resnick, MD |
|Sub-Investigator: Donald Bodner, MD |
University Hospitals of Cleveland
||Allen D Seftel, MD
||University Urologists of Cleveland
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 18, 2005
||November 26, 2007
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Genital Diseases, Male
Pathological Conditions, Anatomical
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Adrenergic alpha-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs