A Phase 3, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
研究概览
简要总结
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males between 18-75 years of age
- •Two fasting serum testosterone levels <300 ng/dL
排除标准
- •Previous use of the study drug
- •History of prostate or breast cancer
- •Prostate-Specific Antigen (PSA) ≥3 ng/mL
- •Subject is sexually active and not willing to use adequate contraception
研究组 & 干预措施
Testosterone gel (FE 999303)
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
干预措施: Testosterone gel (FE 999303) (Drug)
结局指标
主要结局
The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
时间窗: At Day 90
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.
次要结局
- Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone(Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90)
- The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL(At 14, 35 and 56)
- Change From Baseline in Short Form-12 Health Survey (SF-12) Score(At Days 35 and 90)
- Change From Baseline in International Index of Erectile Function (IIEF) Score(At Days 35 and 90)
- Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score(At Days 35 and 90)
- Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone(Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90)
- Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone(Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90)
- Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone(Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90)
- Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone(Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90)