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Completed

NCT Number: NCT00427219

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

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.

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Key information

Conditions

Benign Prostatic Hypertrophy Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Prostatism Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Donald Gleason, MD, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Ozarelix

Drug

Ozarelix 15 mg will be administered IM on Day 0 and Day 14.

Placebo

Drug

Placebo will be administered IM on Day 0 and Day 14.

Primary outcomes

  1. Change From Baseline in International Prostate Symptom Score (IPSS)

    Time frame: 12 weeks

    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 outcomes

  1. International Prostate Symptom Score - Quality of Life (IPSS-QOL)

    Time frame: 36 weeks

    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.

  2. BPH Impact Index (BPHII)

    Time frame: 36 weeks

    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).

  3. Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)

    Time frame: 36 weeks

    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.

  4. International Index of Erectile Function-15 (IIEF-15)

    Time frame: 36 weeks

    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.

  5. Maximum Urinary Flow Rate (Qmax)

    Time frame: 36 weeks

    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.

  6. Number of Participants With Adverse Events

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Spectrum Pharmaceuticals, Inc

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 26, 2007
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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