NCT01097707终止2 期
A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 Weeks in Men With Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
研究概览
简要总结
The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Present at screening with a history of benign prostatic hyperplasia (BPH) for >6 months.
- •Have an International Prostate Symptom Score (IPSS) greater than or equal to 13 at screening.
- •Have a total prostate volume by transrectal ultrasound greater than or equal to 30 milliliter (mL) at screening.
- •Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) greater than or equal to 4 and less than or equal to 15 milliliter/second (mL/sec) (from a prevoid total bladder volume [assessed by ultrasound] of greater than or equal to 150 to less than or equal to 550 ml and a minimum voided volume of 125 ml) at screening.
- •Have a prostate-specific antigen (PSA) greater than or equal to 1.4 and less than or equal to 10 nanogram/milliliter (ng/mL) at screening.
- •Demonstrate a Post Void Residual less than or equal to 300 mL by ultrasound at screening.
- •Have not received the following treatments within the specified time period:
- •Finasteride or dutasteride for at least 6 months prior to screening.
- •Any alpha-adrenergic antagonists for at least 4 weeks prior to screening.
- •Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to screening.
- •Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to screening.
- •Any overactive bladder treatment for at least 4 weeks prior to screening.
- •Any Erectile Dysfunction treatment which may include oral phosphodiesterase type 5 inhibitors or devices for at least 4 weeks prior to screening.
- •Have a morning fasting Total Testosterone concentration greater than or equal to 300 nanogram/deciliter (ng/dL) at screening.
- •If hyperlipidemic, based on history, be stable on statin treatment as determined by the investigator for at least 2 months prior to screening.
排除标准
- •Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY
- •Have any history of BPH-related invasive procedures (for example, Transurethral Resection of the Prostate, open prostatectomy, and minimally invasive procedures that include thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents).
- •Have active cardiovascular disease as evidenced by the following:
- •Recent Myocardial infarction, unstable angina, stroke or Transient ischemic attack within 6 months of screening.
- •Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of screening.
- •Recent history of positive stress tests without any written documentation of effective intervention within 6 months of screening.
- •Evidence of heart disease categorized as greater than or equal to Class III functional classification of New York Heart Association (NYHA) within 6 months of screening.
- •Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin).
- •Have a history of deep venous thrombosis or pulmonary embolism disease.
- •Have moderate to severe renal insufficiency.
- •Have a hemoglobin A1c (HbA1c) greater than 9.0%.
- •Are on testosterone replacement therapy, or drugs that influence the hypothalamus-pituitary-gonadal axis.
- •Are on pharmacological treatment other than statins for hyperlipidemia.
研究组 & 干预措施
10mg LY500307
Experimental
干预措施: LY500307 (Drug)
25mg LY500307
Experimental
干预措施: LY500307 (Drug)
1mg LY500307
Experimental
干预措施: LY500307 (Drug)
3mg LY500307
Experimental
干预措施: LY500307 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
时间窗: Baseline, 24 weeks
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) with an IPSS Total Score range of 0-35 points. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
次要结局
- Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)(Baseline, 24 weeks)
- Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)(Baseline, 24 weeks)
- Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)(Baseline, 24 weeks)
- Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores(Baseline, 24 weeks)
- Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)(Baseline, 24 weeks)
- Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone(Baseline, 24 weeks)
- Change From Baseline to 24-Week Endpoint in Lipid Profile(Baseline, 24 weeks)
研究者
研究点 (1)
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