EUCTR2012-000291-42-ES进行中（未招募）1 期
Effect of treatment with testosterone undecaonat in patients with Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Men older than or equal to 18.
- •2. Submit a diagnosis of diabetes mellitus type 1 and hypogonadotropic hypogonadism, defined as:
- •? Levels of total testosterone <8nmol / L(2.3 ng/mL), or total testosterone levels between 8 and 12 nmol / L (2.3-3.5 ng/mL)and calculated free testosterone <225 pmol / L (65 pg / mL).
- •? Determination of LH below 8.6 mU / mL and / or FSH lower than 14.2 IU / L.
- •3. Being able to provide informed consent before randomization and agree to abide by the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. Existence of chronic debilitating disease such as kidney failure, cirrhosis, HIV, COPD, heart failure, ischemic heart disease.
- •2. Patients with hypergonadotropic hypogonadism.
- •3. Patients diagnosed with panhypopituitarism.
- •4. Patients with hypogonadotropic hypogonadism secondary to pituitary tumor or empty sella.
- •5. Patients with hypogonadotropic hypogonadism secondary to hyperprolactinemia.
- •6. Patients with contraindications to the administration of testosterone: elevated PSA, breast carcinoma, prostate carcinoma, liver tumors
- •7. Patients previously treated with testosterona
- •8. Patients with allergy to testosterone and/or excipients.
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