NCT00962390已完成2 期
Randomized, Double Blind, Multicenter, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy and Safety of 4 Weeks Treatment With AUS 131 (S Equol) on Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 15
- 主要终点
- Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.
详细描述
The study is a phase 2a, randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of S-equol to placebo in patients with benign prostatic hyperplasia. The study objective is to examine a dose response of 3 dose levels of S equol versus placebo on prostate specific antigen concentrations in patients with benign prostatic hyperplasia. The safety of S-equol will be evaluated during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Is male > 50 years of age at Screening.
- •Has a normal digital rectal exam with the exception of prostate enlargement.
- •Has suffered from symptoms of BPH for at least the 6 months before Screening.
- •Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound.
- •Has a serum PSA concentration > 1.5 ng/mL and ≤ 10 ng/mL at Screening.
- •Has an IPSS > 13 at Screening and Baseline.
- •Has a Qmax > 5 cc/sec and < 15 cc/sec with a voided volume ≥ 125 cc at Screening (and Baseline, if applicable).
排除标准
- •Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug.
- •Neurogenic bladder dysfunction.
- •Has bladder neck contracture or urethral stricture.
- •Has acute or chronic prostatitis or urinary tract infection.
- •Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam or transrectal ultrasound, or has a serum PSA concentration > 10 ng/mL; patients with a PSA concentration > 4 ng/mL and ≤ 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator.
- •Has a residual void volume > 250 mL.
- •Has any clinically significant unstable condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
- •Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma).
- •Has a history of smoking more than 5 cigarettes daily within the year before Screening.
- •Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg or < 60 mmHg at Screening.
- •Has bladder stones as detected by ultrasound.
- •Has hematuria of unknown etiology.
- •Had previous prostate surgery or other invasive treatment for BPH.
- •Had prior radiation to the pelvis.
- •Has Parkinson's disease or multiple sclerosis.
- •Had stroke or myocardial infarction within 5 months before Baseline.
- •Has abnormal screening electrocardiogram (ECG) or unstable angina or severe congestive heart failure.
- •Has active liver disease renal insufficiency with creatinine > 1.7 mg/dL, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count.
- •Has a history of postural hypotension or has a fall in systolic BP > 20 mm Hg after 2 minutes in a standing position.
- •Received alpha blocker therapy within 28 days before Baseline.
- •Received androgens, anti androgens, 5 alpha reductase inhibitors, or luteinizing hormone releasing hormone (LHRH) analogs within 3 months before Baseline.
- •Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1 month before Baseline.
- •Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week before Baseline.
- •Has initiated new use (i.e., within the past 4 weeks before Screening) or otherwise are not on stable doses of phosphodiesterase 5 inhibitors during the 4 weeks before Screening.
- •Has known or suspected history of alcoholism or drug abuse or misuse within the last 5 years.
- •Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Clinical Investigator's Brochure for AUS 131 [S equol]), to be an unsuitable candidate to receive the study drug.
- •Has tested positive on the urine drug screen.
研究组 & 干预措施
150mg S-equol
Experimental
干预措施: S-equol (Drug)
50mg S-equol
Experimental
干预措施: S-equol (Drug)
10 mg S-equol
Experimental
干预措施: S-equol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.
时间窗: 4 weeks
Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study.
次要结局
- Change in Prostate Volume From Baseline at Week 4(4 weeks)
- Change in Qmax From Baseline at Week 4(4 weeks)
- Categorical Change in Qmax From Baseline at Week 4(4 weeks)
- Percent Change in Qmax From Baseline at Week 4(4 weeks)
- Change in Void Volume From Baseline at Week 4(4 weeks)
- Change in Post-Void Residual Volume From Baseline at Week 4(4 weeks)
- Change in I-PSS Total Score From Baseline at Week 4(4 weeks)
- Change in in Dihydrotestosterone Concentration From Baseline at Week 4(4 weeks)
- Change in Luteinizing Hormone Concentration From Baseline at Week 4(4 weeks)
- Participants Assessment of Nocturia at Week 4(4 weeks)
- Change in Total Testosterone Concentration From Baseline at Week 4(4 weeks)
- Investigators Assessment of Nocturia at Week 4(4 weeks)
- Change in DAN Prostate Symptom Scale From Baseline at Week 4(4 weeks)
研究者
研究点 (15)
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