Phase II, Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of Org 3236 Tablets in Men With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo
研究概览
简要总结
This trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on:
- the prostate volume and the urinary complaints;
- the urinary flow and the urinary volume in the bladder after voiding;
- the progression of the disease;
- the sexual function, well-being and urinary complaints-related Quality of Life. In addition the safety and the way the drug is absorbed and excreted by the body will be analyzed.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent, obtained before screening evaluations;
- •Men diagnosed with LUTS suggestive of BPH: Baseline IPSS score of = 12 (moderate to severe); Prostate volume of = 40 mL and < 100 mL (based on TRUS); Peak urinary flow rate = 15 mL/s with a voided volume of =125 mL
- •Age at least 50 but not older than 80 years at screening
- •PSA < 10 ng/mL and exclusion of prostate cancer to the satisfaction of the investigator (e.g. by biopsy)
排除标准
- •A post void residual volume >250 mL
- •Use of drugs interfering with efficacy assessments within two weeks or six months prior to start treatment (depending on drug)
- •Acute urinary retention within the past 12 months
- •History of surgery for BPH, including other minimally invasive procedures
- •Presence of urinary tract infection
- •Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation
- •Cardiac or cerebrovascular event within the past six months
- •Presence or history of any neurological disease associated with primary bladder dysfunction
- •Presence or history of liver/renal disease or disturbance of liver/renal function that failed to return to normal
- •Clinically relevant abnormal laboratory result as judged by the (sub)investigator
研究组 & 干预措施
Arm 1
etonogestrel
干预措施: etonogestrel (Drug)
Arm 2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo
时间窗: Screening and weeks 4 - 24; screening and weeks 2 - 24, respectively
The safety of Org 3236
时间窗: Screening up to and including week 24
The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties
时间窗: Randomization and weeks 2 - 8; randomization and weeks 2 - 12 and 24, respectively
The effect of Org 3236 on prostate volume compared to placebo
时间窗: Screening (days -30 to -1), weeks 8, 12 and 24
The effect of Org 3236 on LUTS compared to placebo
时间窗: Screening up to and including week 24
The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo
时间窗: Screening and weeks 2 - 24
The effect on progression of LUTS
时间窗: Screening up to and including week 24
次要结局
未报告次要终点