Influence on Human Male Fertility of Testosterone After Intranasal (MPP10) or Transdermal (AndroGel™) Application
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups.
研究概览
简要总结
Exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and constant testosterone levels will cause a drop in FSH and LH production by the pituitary. Since FSH and LH are signalling hormones to the testes, endogenous testosterone production and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the morning will mimic the normal physiological pattern of testosterone production thereby avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone levels more or less constant over the day and will very likely have inhibitory effects on spermatogenesis.
The main objective of this study is to show that twice daily intranasal dosing does not have, or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal testosterone gels.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 50 years but not older than 80 years of age;
- •Serum testosterone level <13.8 nmol/l;
- •Sperm concentration > 40 Million/ml;
- •Willing to give written informed consent.
排除标准
- •Testicular diseases or having had any surgical procedures applied to the testes;
- •History or currently existing serious disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
- •Current androgen, anabolic steroid or sex hormone treatment or any treatment with such compounds in the previous 6 months;
- •Blood donation within the 12-week period before the initial study dose.
- •History of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea;
- •Elevated serum PSA levels (> 4 ng/ml for subjects >= 50 years of age);
研究组 & 干预措施
Group 1
Group 1 will be treated with MPP10, 7.6 mg, twice daily to be taken immediately after waking up and washing/showering (approx. 7:00-8:00 AM) and at lunch time (approx. 12:00 AM).
干预措施: MPP10, testosterone (Drug)
Group 2
Group 2 will be treated with AndroGel® 50 mg, once daily in the morning after washing/showering.
干预措施: Testosterone (Drug)
结局指标
主要结局
The main study parameter is the change in sperm concentration during the 4-month study period for each of the two treatment groups.
时间窗: 4 months
次要结局
- The effects of treatment on the health related quality of life (QoL);(4 months)
- The influence of transdermal and intranasal testosterone treatment on morphology and motility on sperm cells and on the volume of the ejaculate;(4 months)