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

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)

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hypertrophy
• Intervention / Treatment: Drug: Ozarelix; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Donald Gleason, MD
  • California
    • Laguna Hills, California, United States, 92653
      • Jay Young, MD
    • Los Angeles, California, United States, 90048
      • Alexander Gershman, MD
    • Newport Beach, California, United States, 92660
      • Stephen Auerbach, MD
    • Tarzana, California, United States, 91356
      • Eugene Dula, MD
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Joel Kaufman, MD
  • Florida
    • Ocala, Florida, United States, 34474
      • Ira Klimberg, MD
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Joseph Williams, MD
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Christopher Steidle, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • Steven Bigg, MD
  • New York
    • New York, New York, United States, 10016
      • Jed Kaminetsky, MD
  • Texas
    • San Antonio, Texas, United States, 78229
      • William Fitch, MD
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Gregg Eure, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozarelix; 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.	Drug: Ozarelix; Ozarelix 15 mg will be administered IM on Day 0 and Day 14.
Placebo Comparator: Placebo; 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.	Drug: Placebo; Placebo will be administered IM on Day 0 and Day 14.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 weeks
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).	36 weeks
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.	36 weeks
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.	36 weeks
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.	36 weeks
Number of Participants With Adverse Events		36 weeks

Collaborators and Investigators

• Sponsor: Spectrum Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2007
• Primary Completion (Actual): February 27, 2008
• Study Completion (Actual): February 27, 2008

Study Registration Dates

• First Submitted: January 24, 2007
• First Submitted That Met QC Criteria: January 24, 2007
• First Posted (Estimate): January 26, 2007

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Prostatic Hypertrophy, Benign; Adenoma, Prostatic; Enlarged Prostate; Prostatism; Prostatic Adenoma, Benign
• Additional Relevant MeSH Terms: Urological Manifestations; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Hypertrophy
• Other Study ID Numbers: SPI-153-06-1