EUCTR2012-001258-25-ES进行中（未招募）1 期
A phase III, multi-center, open label, uncontrolled trial to investigate the efficacy and safety of MK-8962 (corifollitropin alfa) in combination with human Chorionic Gonadotropin (hCG) in inducing increased testicular volume and spermatogenesis in adult men with hypogonadotropic hypogonadism who remain azoospermic when treated with hCG alone (Phase III; Protocol No. MK-8962-031-00 [also known as SCH 900962, P07937]) - Corifollitropin alfa trial in adult men with hypogonadotropic hypogonadism (HH)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •-Each subject must have been diagnosed with HH, either congenital or acquired. Note: Subjects with drug-induced HH (e.g. misuse of anabolic steroids, chronic use of glucocorticoids or narcotic analgesics, etc.) are not allowed to participate.
- •-Each subject must be ?18 to ?50 years of age at the time of signing ICF.
- •-Each subject must have low circulating levels of Testosterone (T): T ? 6 nmol/L, as assessed after an adequate wash-out period from previous testosterone use (if applicable).
- •-Each subject must have low circulating levels of gonadotropins: follicle stimulating hormone (FSH) ? 2 IU/L and luteinizing hormone (LH) ? 2 IU/L (after adequate wash-out from previous testosterone use [if applicable]).
- •- Each subject must have presence of scrotal testes (left and right).
- •- Each subject must have azoospermia (according to the World Health Organization [WHO] criteria).
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-The subject has primary hypogonadism, such as Klinefelter's syndrome.
- •-The subject has a history of unilateral or bilateral cryptorchidism (maldescended testes). Note:
- •Subjects with a history of unilateral cryptorchidism which was treated before the age of 2 years are allowed in this trial.
- •- The subject has a history or presence of testicular pathology of clinical importance (e.g., epididymitis,
- •orchitis, testicular torsion, varicocele stage III, testicular atrophy, occlusive azoospermia, etc), and/or vasectomy.
- •- The subject has been treated with FSH, hCG or gonadotropin releasing hormone (GnRH) within a period of three months prior to signing informed consent or for more than one month within a period of six months prior to signing informed consent.
- •-The subject has proven spermatogenesis upon hCG treatment alone.
- •- The subject has had a previous unsuccessful attempt with hCG in combination with human menopausal gonadotropin (hMG)/FSH to achieve spermatogenesis.
- •- The subject had required a dose of hCG of more than 6000 IU per week in a previous attempt to normalize T levels.
- •- The subject has untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or hypothalamic tumor that is likely to progress during the trial.
- •- The subject has had hypophysectomy within a period of 6 months prior to the start of screening.
- •At Visit 6 / Day 1
- •Key Inclusion Criteria:
- •- Each subject must have circulating T levels within the normal range
- •- Each subject must still have azoospermia (according to WHO criteria).
研究者
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