EUCTR2019-004677-12-IT进行中（未招募）1 期
Pharmacodynamics and safety of human recombinant luteinising hormone in hypogonadotropic hypogonadal men. - Rec-LH PD and safety profile in hypogonadotropic hypogonadism Men
IVERSITA' DEGLI STUDI DI MODENA E REGGIO EMILIA - DIPARTIMENTO DI SCIENZE BIOMEDICHE, METABOLICHE E NEUROSCIENZE0 个研究点目标入组 32 人开始时间: 2020年10月7日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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
- •Age between 18 and 45 years
- •Acquired hypogonadotropic hypogonadism forms:
- •oHypogonadotropic hypogonadism after neurosurgery for tumors (i.e. pituitary adenoma, including prolactinoma, craniopharyngioma, germinomas, meningiomas, gliomas, and astrocytomas). OR
- •oHypogonadotropic hypogonadism due to pituitary adenoma-related mass effect, in case of cured or controlled hormone hypersecretion
- •Total testosterone serum levels below the normal ranges (lower than 3 ng/mL)
- •No androgen replacement therapies in the last three months before enrolment. On the other hand, when the patient was treated with intramuscular testosterone formulations, they must be changed into gel formulations at least in the six months before enrolment. When the patient was treated with androgens in gel formulations, they must be stopped 15 days before enrolment.
- •No current hyper-secretion of other pituitary hormones
- •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 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Congenital hypogonadotropic hypogonadism forms, such as: Congenital combined pituitary hormone deficiency; Genetic syndromes (e.g., Prader-Labhart-Willi, CHARGE, Lawrence-Moon-Bardet-Biedl)
- •Acquired HH forms due to Infiltrative disease (hemochromatosis, granulomatous disease, histiocytosis, and sarcoidosis)
- •Use of anabolic steroids and/or chronic non-replacement steroid therapies
- •Drug and alcohol abuse
- •Major systemic diseases, such as chronic severe liver disease, active malignancy diseases, cardiac failure, hypertension, renal dysfunction, migraines, or epilepsy (since aggravation or recurrence may occasionally be induced as a result of increased androgen production)
- •Concomitant illnesses which could interfere with the study participation
- •Medical history of androgen-dependent tumors (i.e. male breast carcinoma or prostatic carcinoma)
- •Haematocrit <40% or >54%
研究者
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