Corifollitropin alfa trial in adult men with hypogonadotropic hypogonadism (HH).
- Conditions
- Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]Hypogonadotrophic hypogonadism:Hypogonadotropic hypogonadism (HH) in males may result from either absent or inadequate gonadotropin-releasing hormone (GnRH) secretion by the hypothalamus or failure of pituitary gonadotropin secretion (luteinizing hormone (LH) & follicle stimulating hormone (FSH)). HH is characterized by androgen deficiency and by inappropriately low serum concentrations of LH and FSH.MedDRA version: 17.1Level: LLTClassification code 10021012Term: Hypogonadotrophic hypogonadismSystem Organ Class: 100000004860
- Registration Number
- EUCTR2012-001258-25-Outside-EU/EEA
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Male
- Target Recruitment
- 20
Each subject must be a male, diagnosed with hypogonadotropic hypogonadism (either congenital or acquired), and be =18 to =50 years of age at the time of signing ICF. (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 have low circulating levels of Testosterone (T): T = 6 nmol/L, and low circulating levels of gonadotropins (FSH = 2 IU/L and LH = 2 IU/L), as assessed after an adequate wash-out period from previous testosterone use (if applicable). Each subject must have presence of scrotal testes (left and right) and must have azoospermia (according to the criteria specified in the 2010 World Health Organization [WHO] Laboratory Manual for the Examination and Processing of Human Semen, 5th Edition). Each subject must have adequate replacement of other pituitary hormones (if applicable).
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
The subject has primary hypogonadism such as Klinefelter's syndrome, or 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 testicular pathology of clinical importance (e.g., epididymitis, orchitis, testicular torsion, varicocele stage III, testicular atrophy, occlusive azoospermia, etc). 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, or 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 study. The subject has had hypophysectomy within a period of 6 months prior to the start of screening. The subject has a history or presence (known or suspected) of testicular, prostatic or breast cancer, has prostate pathology of clinical importance, or has past or present oncological treatment (chemo/radiotherapy). (Note: Previous local radiation of the brain in case of a pituitary tumor is allowed, but not in case of brain metastases). The subject has diabetes mellitus, untreated hyperprolactinaemia or uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders). The subject has tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C (results obtained within 1 year prior to signing ICF are considered valid).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method