The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00427219
First received: January 24, 2007
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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/Placebo
Drug: Placebo
Phase 2
Phase 3

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: 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)

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Improvement in IPSS compared to placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IPSS subscores; IPSS QOL ;BII;LUTS GAQ;Qmax;To examine the effect of ozarelix on erectile function in sexually active men;To assess the safety and tolerability of ozarelix [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo run-in phase
Eligible patients entered a placebo run-in phase in which placebo was administered twice over a 2 week period (Day -28 and Day -14) and patients were assessed to establish baseline values approximately 14 days following the second placebo injection
Drug: Placebo
Eligible patients entered a placebo run-in phase in which placebo was administered twice over a 2 week period (Day -28 and Day -14) and patients were assessed to establish baseline values approximately 14 days following the second placebo injection
Experimental: Ozarelix/Placebo
All patients completing the placebo run in period were randomized to enter the treatment phase of the study and received either placebo or ozarelix on Day 0 and Day 14
Drug: Ozarelix/Placebo
Ozarelix 15 mg or placebo will be administered IM on Day 0 and Day 14

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All of the following questions must be answered "Yes" at Visit 1 in order for the patient to participate in the study.

  • Is the patient at least 50 years old?
  • Does the patient have clinical signs and symptoms consistent with BPH?
  • Does the patient have an IPSS ³13 at screening (prior to placebo run in)?
  • Does the patient have a peak urinary flow rate (Qmax) of 4-15 mL/sec established on a voided volume of at least 125 mL?
  • Is the patient willing to agree not to use any other approved or experimental pharmacologic BPH treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during 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.

  • Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL?
  • Has the patient had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy?
  • Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL?
  • Does the patient have a residual urine volume > 350 mL by ultrasound?
  • Has the patient taken or is currently taking any of the following:
  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: NCT00427219

Locations
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
Stephen Auerbach, MD
Newport Beach, California, United States, 92660
Eugene Dula, MD
Tarzana, California, United States, 91356
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
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00427219     History of Changes
Other Study ID Numbers: SPI-153-06-1
Study First Received: January 24, 2007
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:
Benign Prostatic Hyperplasia
Prostatic Adenoma, Benign
Prostatic Hypertrophy, Benign
Enlarged Prostate
Prostatism
Adenoma, Prostatic

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Hypertrophy
Prostatic Hyperplasia
Urological Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on September 18, 2014