A Multicenter Extension Trial to Evaluate the 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
- 145
- 试验地点
- 18
- 主要终点
- Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
研究概览
简要总结
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
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
- •Completion of the Phase 3 protocol (NCT01665599)
排除标准
- •Use of another investigational product
- •Use of any medications that could be considered anabolic or interfere with androgen metabolism
- •Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
- •Use of another testosterone product
- •Chronic use of any drug of abuse
研究组 & 干预措施
Testosterone gel (FE 999093)
Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
干预措施: Testosterone Gel (FE 999093) (Drug)
结局指标
主要结局
Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
时间窗: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics.
次要结局
- Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone(Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month))
- Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire(At Month 6)
- Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.(Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month))
- Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL(At Month 6)
- Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone(Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month))
- Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire(At Month 6)
- Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire(At Month 6)
- Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone(Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month))
- Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone(Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month))
- Domain Scores for the Short Form-12 (SF-12) Questionnaire(At Month 6)
- Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone(Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month))