Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Spectrum Pharmaceuticals, Inc |
---|---|
Information provided by: | Spectrum Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00427219 |
This study will compare the efficacy and safety of ozarelix 15 mg. given IM 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with BPH who are over 50 years of age.
Condition | Intervention | Phase |
---|---|---|
Benign Prostatic Hypertrophy |
Drug: ozarelix |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Ozarelix, in Patients With Lower Urinary Tract Symptoms(LUTS)Due to Benign Prostatic Hypertrophy (BPH) |
Estimated Enrollment: | 75 |
Study Start Date: | January 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
This study will compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from LUTS secondary to BPH following treatment with ozarelix. Ozarelix will be compared to placebo and injections will be given 14 days apart. Patients will be followed for 6 months and both safety and efficacy will be assessed at monthly visits.Additionally the impact of treatment on erectile function, if any, as well as PSA and Testosterone levels will be monitored.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All of the following questions must be answered "Yes" at Visit 1 in order for the patient to participate in the study.
Exclusion Criteria: All of the following questions must be answered "No" at Visit 1 in order for the patient to participate in the study.
United States, Arizona | |
Donald Gleason, MD | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Jay Young, MD | |
Laguna Hills, California, United States, 92653 | |
Alexander Gershman, MD | |
Los Angeles, California, United States, 90048 | |
Eugene Dula, MD | |
Tarzana, California, United States, 91356 | |
Stephen Auerbach, MD | |
Newport Beach, California, United States, 92660 | |
United States, Colorado | |
Joel Kaufman, MD | |
Aurora, Colorado, United States, 80012 | |
United States, Florida | |
Ira Klimberg, MD | |
Ocala, Florida, United States, 34474 | |
United States, Idaho | |
Joseph Williams, MD | |
Meridian, Idaho, United States, 83642 | |
United States, Indiana | |
Christopher Steidle, MD | |
Ft. Wayne, Indiana, United States, 46825 | |
United States, Missouri | |
Steven Bigg, MD | |
St. Louis, Missouri, United States, 63136 | |
United States, New York | |
Jed Kaminetsky, MD | |
New York, New York, United States, 10016 | |
United States, Texas | |
William Fitch, MD | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Gregg Eure, MD | |
Virginia Beach, Virginia, United States, 23454 |
Study ID Numbers: | SPI-153-06-1 |
Study First Received: | January 24, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00427219 |
Health Authority: | United States: Food and Drug Administration |
Benign Prostatic Hyperplasia Prostatic Adenoma, Benign Prostatic Hypertrophy, Benign |
Enlarged Prostate Prostatism Adenoma, Prostatic |
Pathological Conditions, Anatomical Hypertrophy Hyperplasia Prostatic Diseases |
Prostatic Hyperplasia Genital Diseases, Male Adenoma |