An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- AUC0-t of Serum Testosterone
研究概览
简要总结
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels >100 ng/dl and ≤ 300 ng/dL.
- •Normal Otolaryngological nasal endoscopy examination.
- •Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.
排除标准
- •Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex hormones
- •Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12 months
- •History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery.
- •History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.
研究组 & 干预措施
10.0 mg of TBS-1, 4.0% T.I.D.
TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
干预措施: 10.0 mg of Testosterone, 4.0% TID (Drug)
13.5 mg of TBS-1, 4.5% B.I.D
TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
干预措施: 13.5 mg of Testosterone, 4.5% B.I.D (Drug)
11.25 mg of TBS-1, 4.5% T.I.D
TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
干预措施: 11.25 mg of Testosterone, 4.5% T.I.D (Drug)
结局指标
主要结局
AUC0-t of Serum Testosterone
时间窗: 24 hours
Cmax of Serum Testosterone
时间窗: 24 hours
Cavg of Serum Testosterone
时间窗: 24 hours
次要结局
未报告次要终点