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

Primary Purpose

Benign Prostatic Hypertrophy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ozarelix
Placebo
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy focused on measuring Benign Prostatic Hyperplasia, Prostatic Adenoma, Benign, Prostatic Hypertrophy, Benign, Enlarged Prostate, Prostatism, Adenoma, Prostatic

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

  • Is the participant at least 50 years old?
  • Does the participant have clinical signs and symptoms consistent with BPH?
  • Does the participant have an IPSS 13 at screening (prior to placebo run in)?
  • Does the participant have a peak urinary flow rate (Qmax) of 4-15 milliliter/second (mL/sec) established on a voided volume of at least 125 mL?
  • Is the participant 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 participant to participate in the study.

  • Does the participant have a history of prostate cancer or a serum PSA >10 nanograms per milliliter (ng/mL)?
  • Has the participant had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy?
  • Does the participant have a prevoid total bladder volume assessed by ultrasound > 550 mL?
  • Does the participant have a residual urine volume > 350 mL by ultrasound?

Sites / Locations

  • Donald Gleason, MD
  • Jay Young, MD
  • Alexander Gershman, MD
  • Stephen Auerbach, MD
  • Eugene Dula, MD
  • Joel Kaufman, MD
  • Ira Klimberg, MD
  • Joseph Williams, MD
  • Christopher Steidle, MD
  • Steven Bigg, MD
  • Jed Kaminetsky, MD
  • William Fitch, MD
  • Gregg Eure, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ozarelix

Placebo

Arm Description

All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received ozarelix on Day 0 and Day 14.

All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received placebo Day 0 and Day 14.

Outcomes

Primary Outcome Measures

Change From Baseline in International Prostate Symptom Score (IPSS)
IPSS is a validated self-administered index for grading benign prostatic hyperplasia (BPH)-related signs and symptoms. It consists of a set of seven questions. A total score of 1-7 indicates mild disease, 8-19 moderate disease and 20-35 severe disease.

Secondary Outcome Measures

International Prostate Symptom Score - Quality of Life (IPSS-QOL)
IPSS QOL is a disease-specific quality of life question, referred to as IPSS Question 8. Participants with an IPSS QOL of <3 at screening will be excluded from this study. The rating is as follows: 0=delighted, 1=pleased, 2=mostly satisfied, 3=mixed, 4=mostly dissatisfied, 5=unhappy, 6=terrible.
BPH Impact Index (BPHII)
BPH Impact Index (BII) is used to assess the impact of BPH on various aspects of health. This 4 question self administered index uses a scoring range from 0 (best) to 13 (worst).
Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
The self administered LUTS GAQ is a "yes" or "no" response to a question asking whether overall improvement in LUTS will be observed during the treatment period.
International Index of Erectile Function-15 (IIEF-15)
International Index of Erectile Function Erectile Function Domain (IIEF-EF) will be used to assess the effect of ozarelix on erectile function in sexually active men. IIEF-EF is defined as the sum of the scores for Questions 1-5 and 15 of the IIEF questionnaire. This recall instrument is self-administered by the participant. Individual questions are graded from 1 to 5 with a maximum total score of 30. Lower IIEF-EF scores represent diminished erectile function. Men with a score of ≥ 26 are interpreted as having normal erectile function.
Maximum Urinary Flow Rate (Qmax)
Qmax was measured by free flow uroflowmetry. Qmax is defined as the peak urine flow rate (measured in milliliter (mL)/second using a standard calibrated flowmeter). For a Qmax to be considered valid, the voided volume had to be at least 125 mL. The uroflowmeter is to be calibrated weekly.
Number of Participants With Adverse Events

Full Information

First Posted
January 24, 2007
Last Updated
October 12, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00427219
Brief Title
The Safety and Efficacy of Ozarelix to Treat Men With Lower Urinary Tract Symptoms Due to Enlargement of the Prostate
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 23, 2007 (Actual)
Primary Completion Date
February 27, 2008 (Actual)
Study Completion Date
February 27, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

5. Study Description

Brief Summary
This study is to compare the efficacy and safety of ozarelix 15 mg given intramuscular (IM) 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with Benign Prostatic Hypertrophy (BPH) who are over 50 years of age.
Detailed Description
This study is to compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from lower urinary tract symptoms (LUTS) secondary to Benign Prostatic Hypertrophy (BPH) following treatment with ozarelix. Ozarelix is compared to placebo and injections given 14 days apart. Patients are followed for 6 months and both safety and efficacy assessed at monthly visits. Additionally, the impact of treatment on erectile function, if any, as well as Prostate-Specific Antigen (PSA) and Testosterone levels will be monitored. The screening period of 7 days. The duration of the study is 40 weeks, including a 28-day placebo run-in phase (eligible participants entered a placebo run-in phase in which placebo is administered twice over a 2 week period [Day -28 and Day -14] and participants are assessed to establish baseline values approximately 14 days following the second placebo injection), study drug is administered on Days 0 and 14 followed by 34 weeks of observation after the last dose of study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy
Keywords
Benign Prostatic Hyperplasia, Prostatic Adenoma, Benign, Prostatic Hypertrophy, Benign, Enlarged Prostate, Prostatism, Adenoma, Prostatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozarelix
Arm Type
Experimental
Arm Description
All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received ozarelix on Day 0 and Day 14.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received placebo Day 0 and Day 14.
Intervention Type
Drug
Intervention Name(s)
Ozarelix
Intervention Description
Ozarelix 15 mg will be administered IM on Day 0 and Day 14.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered IM on Day 0 and Day 14.
Primary Outcome Measure Information:
Title
Change From Baseline in International Prostate Symptom Score (IPSS)
Description
IPSS is a validated self-administered index for grading benign prostatic hyperplasia (BPH)-related signs and symptoms. It consists of a set of seven questions. A total score of 1-7 indicates mild disease, 8-19 moderate disease and 20-35 severe disease.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score - Quality of Life (IPSS-QOL)
Description
IPSS QOL is a disease-specific quality of life question, referred to as IPSS Question 8. Participants with an IPSS QOL of <3 at screening will be excluded from this study. The rating is as follows: 0=delighted, 1=pleased, 2=mostly satisfied, 3=mixed, 4=mostly dissatisfied, 5=unhappy, 6=terrible.
Time Frame
36 weeks
Title
BPH Impact Index (BPHII)
Description
BPH Impact Index (BII) is used to assess the impact of BPH on various aspects of health. This 4 question self administered index uses a scoring range from 0 (best) to 13 (worst).
Time Frame
36 weeks
Title
Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)
Description
The self administered LUTS GAQ is a "yes" or "no" response to a question asking whether overall improvement in LUTS will be observed during the treatment period.
Time Frame
36 weeks
Title
International Index of Erectile Function-15 (IIEF-15)
Description
International Index of Erectile Function Erectile Function Domain (IIEF-EF) will be used to assess the effect of ozarelix on erectile function in sexually active men. IIEF-EF is defined as the sum of the scores for Questions 1-5 and 15 of the IIEF questionnaire. This recall instrument is self-administered by the participant. Individual questions are graded from 1 to 5 with a maximum total score of 30. Lower IIEF-EF scores represent diminished erectile function. Men with a score of ≥ 26 are interpreted as having normal erectile function.
Time Frame
36 weeks
Title
Maximum Urinary Flow Rate (Qmax)
Description
Qmax was measured by free flow uroflowmetry. Qmax is defined as the peak urine flow rate (measured in milliliter (mL)/second using a standard calibrated flowmeter). For a Qmax to be considered valid, the voided volume had to be at least 125 mL. The uroflowmeter is to be calibrated weekly.
Time Frame
36 weeks
Title
Number of Participants With Adverse Events
Time Frame
36 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - All of the following questions must be answered "Yes" at Visit 1 in order for the participant to participate in the study. Is the participant at least 50 years old? Does the participant have clinical signs and symptoms consistent with BPH? Does the participant have an IPSS 13 at screening (prior to placebo run in)? Does the participant have a peak urinary flow rate (Qmax) of 4-15 milliliter/second (mL/sec) established on a voided volume of at least 125 mL? Is the participant 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 participant to participate in the study. Does the participant have a history of prostate cancer or a serum PSA >10 nanograms per milliliter (ng/mL)? Has the participant had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy? Does the participant have a prevoid total bladder volume assessed by ultrasound > 550 mL? Does the participant have a residual urine volume > 350 mL by ultrasound?
Facility Information:
Facility Name
Donald Gleason, MD
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Jay Young, MD
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Alexander Gershman, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stephen Auerbach, MD
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Eugene Dula, MD
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Joel Kaufman, MD
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Ira Klimberg, MD
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Joseph Williams, MD
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Christopher Steidle, MD
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Steven Bigg, MD
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Jed Kaminetsky, MD
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
William Fitch, MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Gregg Eure, MD
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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