A Single-centre, Open-label, Randomised Explorative Pharmacokinetic/Pharmacodynamic Study of the Gonadotropin-releasing Hormone Receptor Antagonist Degarelix (FE 200486) in Patients With Benign Prostatic Hyperplasia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Minimal Value of Testosterone (Cnadir)
研究概览
简要总结
This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.
详细描述
The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing regimens (32 and 64 mg administered either as a single administration or as two administrations separated by 14 days) will be evaluated for 42 days.
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
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:
- •Man, 55 to 75 years of age.
- •Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
- •A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
- •Has a baseline testosterone level above 3 ng/mL at screening.
排除标准
- •Any patient meeting one or more of the following exclusion criteria will not be included into the study:
- •Previous surgery of the prostate.
- •Previous treatment with GnRH agonists or GnRH antagonists.
- •Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
- •Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
- •Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
研究组 & 干预措施
Degarelix 16+16 mg
干预措施: Degarelix (Drug)
Degarelix 32 mg
干预措施: Degarelix (Drug)
Degarelix 32+32 mg
干预措施: Degarelix (Drug)
Degarelix 64 mg
干预措施: Degarelix (Drug)
结局指标
主要结局
Minimal Value of Testosterone (Cnadir)
时间窗: Day 0-42
The lowest concentration of testosterone measured within the time frame
Time of Minimal Value of Testosterone (Tnadir)
时间窗: Day 0-42
The time point when the lowest testosterone concentration was measured
Duration of Testosterone Concentration Below 0.5 ng/mL
时间窗: Day 0-42
The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level
Testosterone Area Below Baseline Interval
时间窗: 0-42 Days
The area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)
Time of Testosterone Concentration Below Baseline Interval
时间窗: Day 0-42
The time from when the testosterone concentration falls below the baseline interval limit (i.e. 0.75 x baseline concentration) until it returns above this limit
Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction
时间窗: Day 0-42
The IIEF contains 15 items in 5 domains: Erectile Function (6 items), Orgasmic Function (2 items), Sexual Desire (2 items), Intercourse Satisfaction (3 items), and Overall Satisfaction (2 items). Item are scored on a scale from 'No sexual activity' to 'Almost always to always'. For the Erectile Function domain, a score of 1-10 indicates severe erectile dysfunction and 26-30 no dysfunction, the minimum score being 1 and the maximum 30. For all other domains, a higher score indicates less dysfunction. The IIEF does not yield a total score.
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
时间窗: Day 0-42
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
时间窗: Day 0-42
The baseline interval concentration is 0.75 x baseline concentration
Prostate Specific Antigen (PSA) Concentration
时间窗: Day 0-42
Prostate Volume
时间窗: Day 0-42
The prostatic volume was measured by transrectal ultrasound. The prostatic gland was sonicated from two directions perpendicular to one another resulting in three cursor positions set by the urologist, and the volume automatically calculated.
Maximal Urinary Flow
时间窗: Day 0-42
Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.
Post-void Residual Urine Volume
时间窗: Day 0-42
The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically.
International Prostate Specific Symptom (IPSS) Score
时间窗: Day 0-42
The IPSS is a patient-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic).
IPSS Global Quality of Life
时间窗: Day 0-42
Patients were asked about how they would feel if they were to spend the rest of their lives with their prostate symptoms just as they are now. The answers choices range from "delighted" to "terrible" or 0 to 6.
次要结局
- Pharmacokinetic Parameters of Degarelix: AUCt(0-42 Days)
- Pharmacokinetic Parameters of Degarelix: Cmax(Day 0-42)
- Pharmacokinetic Parameters of Degarelix: Tmax(Day 0-42)