Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH)

Phase 2

Terminated

Conditions: Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms (LUTS)

Interventions: Drug: Placebo
Drug: ozarelix

Registration Number: NCT00743184

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Brief Summary: This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in men as assessed by the International Prostate Symptom Score (IPSS) at Week 14.

Detailed Description: This is a multi-center, randomized, double-blind, placebo-controlled study.

Participants who meet the entry IPSS inclusion criteria at Week 0 will be randomized and enroll in the double-blind treatment period. Participants will be randomized to one of three treatment arms and will receive two 6-month courses of study drug administered on Days 0 and 14 of each 6-month course. Treatment arms include: ozarelix 30mg + 15mg, ozarelix 15mg + 15mg or placebo + placebo. Safety and efficacy assessments will be performed at defined intervals throughout the study. At Week 52 all participants on study will be eligible to receive ozarelix for two additional courses in the open-label treatment period.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Placebo	Placebo	Participants will receive Placebo + Placebo on Days 0 and 14 of each 6-month course.
15 mg Ozarelix + 15 mg Ozarelix	ozarelix	Participants will receive 15 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course.
30 mg Ozarelix + 15 mg Ozarelix	ozarelix	Participants will receive 30 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course.

Primary Outcome Measures

Name	Time	Method
Change From Baseline International Prostate Symptom Score (IPSS) Score at Week 14	Week 14	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

Name	Time	Method
Change From Baseline IPSS (Including Sub-scores) at Week 52	Week 52	The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). 1) Voiding- The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). 2) Storage- The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). Voiding and Storage: the lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). Voiding and Storage: each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. And 3) QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible).
Change From Baseline Benign Prostatic Hyperplasia Impact Index (BPHII) Score at Week 14 and Week 52	Weeks 14 and 52	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).
Change From Baseline International Index of Erectile Function-15 (IIEF-EF) Score at Week 14 and Week 52	Week 14 and Week 52	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 IIEFEF scores represent diminished erectile function. Men with a score of ≥ 26 are interpreted as having normal erectile function.
Change From Baseline International Prostate Symptom Score - Quality of Life (IPSS-QOL) at Week 14 and Week 52	Week 14 and Week 52	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.
Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) Response at Week 52	Week 52	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.
Change From Baseline Maximum Urine Flow (Qmax) at Week 14 and Week 52	Week 14 and Week 52	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 Treatment-Emergent Adverse Events	Up to 104 weeks