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Benign Prostatic HypertrophyPhase 2NCT00427219

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

A Phase 2 study testing Ozarelix in people with Benign Prostatic Hypertrophy, run by Spectrum Pharmaceuticals, Inc at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Benign Prostatic Hypertrophy
What is being tested?
Ozarelix
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
13 sitesUnited States
Study dates
23 Jan 2007to 27 Feb 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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?
Show all 11Show fewer
  • 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?

Who cannot join

None listed.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Joel Kaufman, MD

    Aurora, Colorado, 80012

  • Christopher Steidle, MD

    Fort Wayne, Indiana, 46825

  • Jay Young, MD

    Laguna Hills, California, 92653

  • Alexander Gershman, MD

    Los Angeles, California, 90048

  • Joseph Williams, MD

    Meridian, Idaho, 83642

  • Jed Kaminetsky, MD

    New York, New York, 10016

  • Stephen Auerbach, MD

    Newport Beach, California, 92660

  • Ira Klimberg, MD

    Ocala, Florida, 34474

  • William Fitch, MD

    San Antonio, Texas, 78229

  • Steven Bigg, MD

    St Louis, Missouri, 63136

  • Eugene Dula, MD

    Tarzana, California, 91356

  • Donald Gleason, MD

    Tucson, Arizona, 85712

  • Gregg Eure, MD

    Virginia Beach, Virginia, 23454

Other trials in United States

About this 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)

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.

Read the 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.

Being tested
Ozarelix, Placebo
Keywords
Benign Prostatic Hyperplasia, Prostatic Adenoma, Benign, Prostatic Hypertrophy, Benign, Enlarged Prostate, Prostatism, Adenoma, Prostatic
Medical subject headings
Prostatic Hyperplasia, Prostatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OzarelixDrug

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

  • PlaceboDrug

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

Study groups in NCT00427219
Study groupRoleWhat they receive
OzarelixExperimentalAll 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.
Receives: Drug: Ozarelix
PlaceboPlacebo comparatorAll 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (6)

  1. 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.

    Measured: 36 weeks

  2. 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).

    Measured: 36 weeks

  3. 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.

    Measured: 36 weeks

  4. 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.

    Measured: 36 weeks

  5. 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.

    Measured: 36 weeks

  6. Number of Participants With Adverse Events

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2007 (estimated)
  2. Study start23 Jan 2007
  3. Primary completion27 Feb 2008
  4. Study completion27 Feb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00427219
Sponsor's protocol ID
SPI-153-06-1
Status last verified
Oct 2021
First submitted
24 Jan 2007
Last updated
15 Oct 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ozarelix in people with Benign Prostatic Hypertrophy, run by Spectrum Pharmaceuticals, Inc at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in International Prostate Symptom Score (IPSS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00427219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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